xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017297</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00006462</org_study_id>
      <nct_id>NCT06017297</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma</brief_title>
    <acronym>ESR-22-21719</acronym>
    <official_title>Phase II Study of Neoadjuvant Durvalumab (MEDI4736) and Tremelimumab in Combination With Gemcitabine and Cisplatin in Patients With Intrahepatic Cholangiocarcinoma That is Borderline Resectable/Resectable But With High Risk for Recurrence.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Georgetown University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Georgetown University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test feasibility and safety of the combination of&#xD;
        tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge&#xD;
        patients to a curative resection in treatment naïve borderline resectable, or resectable with&#xD;
        high risk for recurrence intrahepatic cholangiocarcinoma patients. The main question[s] it&#xD;
        aims to answer are:&#xD;
  &#xD;
          -  What is the rate of conversion of unresectable tumor to resectable cancer?&#xD;
  &#xD;
          -  What are the side effects of this treatment combination?&#xD;
  &#xD;
        Participants will undergo an initial tumor biopsy, imaging and laboratory studies prior to&#xD;
        starting treatment with durvalumab, tremelimumab, gemcitabine and cisplatin. Participants&#xD;
        will continue for 4 cycles and if the tumor is found to be resectable then they will undergo&#xD;
        surgical resection. If the tumor is unresectable (can't be surgically removed) after 4&#xD;
        cycles, then participants will receive 4 more cycles and repeated imaging. If the tumor&#xD;
        remains unresectable then the participant will be treated with capecitabine for up to 8&#xD;
        cycles and durvalumab for up to 12 months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2026</completion_date>
    <primary_completion_date type="Anticipated">November 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of Conversion from unresectable to resectable</measure>
      <time_frame>8 Cycles, 21 day cycles</time_frame>
      <description>Rate of conversion of unresectable tumor to resectable cancer after neoadjuvant durvalumab + tremelimumab + gemcitabine + cisplatin after 4 or 8 cycles. Surgical evaluation will be done in joint by institutional radiology and hepatobiliary surgery using clinical data (CT/MRI imaging, patient performance status, labs, etc.) If among the evaluable 24 patients, 9 or more (45%) patients undergo such conversion, the investigational treatment will be considered as promising/feasible. The resectable rate will be estimated with its 95% exact confidence interval.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of related treatment emergent adverse events</measure>
      <time_frame>36 months</time_frame>
      <description>Number of participants with related treatment emergent adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR)</measure>
      <time_frame>36 months</time_frame>
      <description>ORR will be estimated with its 95% exact confidence interval based on RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pathological complete response (pCR)</measure>
      <time_frame>36 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>36 months</time_frame>
      <description>Kaplan-Meier method is used to represent secondary outcome OS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>36 months</time_frame>
      <description>Kaplan-Meier method is used to represent secondary outcome of PFS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of R0 resection</measure>
      <time_frame>8 Cycles, 21 day cycles</time_frame>
      <description>R0 resection rate will be estimated with its 95% exact confidence interval</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relapse free survival (RFS)</measure>
      <time_frame>36 months</time_frame>
      <description>Kaplan-Meier method will be used to analyze RFS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported outcomes (PRO) decline</measure>
      <time_frame>8 Cycles, 21 day cycles</time_frame>
      <description>As measured by qualify of life changes per EORTC QLQ-BIL-20 questionnaires. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Free Survival (EFS)</measure>
      <time_frame>36 months</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Borderline Resectable Carcinoma</condition>
    <condition>Biliary Tract Cancer</condition>
    <arm_group>
      <arm_group_label>Durvalumab and Tremelimumab plus gemcitabine/cisplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Durvalumab and tremelimumab plus gemcitabine/cisplatin combination therapy. If the tumor is evaluated to be resectable after Cycle 4 (C4), then the patient may proceed with surgical tumor resection. If the tumor is deemed unresectable after C4, then the patient will proceed with Cycle 5-8 followed by reevaluation for surgical resection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Durvalumab</intervention_name>
      <description>Durvalumab 1500 mg via intravenous (IV) infusion every 3 weeks for up to 8 cycles</description>
      <arm_group_label>Durvalumab and Tremelimumab plus gemcitabine/cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tremelimumab</intervention_name>
      <description>A single dose of tremelimumab at 300mg IV is given on C1.</description>
      <arm_group_label>Durvalumab and Tremelimumab plus gemcitabine/cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>Gemcitabine is dosed at 1000 mg/m2 IV on day (D)1 and D8 of each cycle.</description>
      <arm_group_label>Durvalumab and Tremelimumab plus gemcitabine/cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Cisplatin is dosed at 25mg/m2 on D1 and D8 of each cycle.</description>
      <arm_group_label>Durvalumab and Tremelimumab plus gemcitabine/cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Surgical Resection</intervention_name>
      <description>If the tumor is evaluated to be resectable (as defined as successfully treated stage II (tumor shrink away from vessels), stage IIIA (tumor shrink away from visceral peritoneum), stage IIIB (N1 disease no longer pathologically enlarged) after C4 or C8, then the patient may proceed with surgical tumor resection.</description>
      <arm_group_label>Durvalumab and Tremelimumab plus gemcitabine/cisplatin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients of age 18 years and older at the time of study entry, both sexes, all&#xD;
               ethnicities.&#xD;
  &#xD;
            2. Patients with histologically proven intrahepatic cholangiocarcinoma, untreated with&#xD;
               systemic therapy.&#xD;
  &#xD;
            3. Patients with an absence of extrahepatic metastasis (outside of periportal lymph node&#xD;
               enlargement) or peritoneal carcinomatosis as demonstrated by CT-scan.&#xD;
  &#xD;
            4. Patients with a performance status ECOG 0, 1.&#xD;
  &#xD;
            5. Patients with an estimated life expectancy &gt; 6 months.&#xD;
  &#xD;
            6. Patients with disease that is not readily suitable for resection with curative intent,&#xD;
               as validated by a multidisciplinary committee with at least one hepatobiliary surgeon,&#xD;
               defined as stage II and stage III disease, surgical resectable if there is tumor&#xD;
               shrinkage.&#xD;
  &#xD;
            7. Patients with at least one measurable lesion according to RECIST 1.1 criteria. Tumor&#xD;
               assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must&#xD;
               be performed within 28 days prior to start of study.&#xD;
  &#xD;
            8. Patients with platelets ≥ 75,000/mm3, polynuclear neutrophils ≥ 1500/mm3, hemoglobin ≥&#xD;
               9g/dL.&#xD;
  &#xD;
            9. Patients with serum creatinine &lt; 1.5 times institutional upper limit of normal (ULN),&#xD;
               measured creatinine clearance &gt; 40 mL/min or Calculated creatinine clearance &gt; 40&#xD;
               mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24 hour urine&#xD;
               collection for determination of creatinine clearance.&#xD;
  &#xD;
           10. Patients with serum bilirubin ≤ 1.5 times institutional upper limit of normal (ULN)&#xD;
               (after biliary drainage if necessary).&#xD;
  &#xD;
           11. Absolute neutrophil count (ANC ≥ 1.0 × 109 /L)&#xD;
  &#xD;
           12. Aspartate aminotransferase (AST or SGOT) / alanine transaminase (ALT or SGPT) ≤ 2.5 x&#xD;
               institutional upper limit of normal unless liver metastases are present, in which case&#xD;
               it must be ≤5x ULN&#xD;
  &#xD;
           13. Patients with a reference CT Scan within 30 days preceding the 1st cycle of treatment.&#xD;
  &#xD;
           14. Patients with US health insurance coverage.&#xD;
  &#xD;
           15. Patients are capable of giving signed informed consent which includes compliance with&#xD;
               the requirements and restrictions listed in the informed consent form (ICF) and in&#xD;
               this protocol. Written informed consent and any locally required authorization (e.g.,&#xD;
               Health Insurance Portability and Accountability Act in the US, European Union [EU]&#xD;
               Data Privacy Directive in the EU) obtained from the patient/legal representative prior&#xD;
               to performing any protocol-related procedures, including screening evaluations.&#xD;
  &#xD;
           16. Patients are willing and able to comply with the protocol for the duration of the&#xD;
               study including undergoing treatment and able to comply with the protocol for the&#xD;
               duration of the study including undergoing treatment and scheduled visits and&#xD;
               examinations including follow up.&#xD;
  &#xD;
           17. Body weight ≥30 kg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with hilar or distal cholangiocarcinoma or those with&#xD;
               hepatocholangiocarcinoma.&#xD;
  &#xD;
            2. Patients who are eligible for surgical resection or liver transplantation based on&#xD;
               tumor characteristics.&#xD;
  &#xD;
            3. Patients who would not be surgical candidates due to reasons unrelated to their&#xD;
               cholangiocarcinoma, e.g. Cirrhosis with portal hypertension&#xD;
  &#xD;
            4. Patients with extrahepatic metastases beyond periportal lymph node enlargement&#xD;
  &#xD;
            5. Patients with a contraindication or grade 3-4 allergy to durvalumab, tremelimumab,&#xD;
               gemcitabine, cisplatin, or capecitabine.&#xD;
  &#xD;
            6. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the&#xD;
               exception of alopecia, vitiligo, and the laboratory values defined in the inclusion&#xD;
               criteria&#xD;
  &#xD;
            7. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after&#xD;
               consultation with the Study Physician.&#xD;
  &#xD;
            8. Patients with irreversible toxicity not reasonably expected to be exacerbated by&#xD;
               treatment with durvalumab or tremelimumab may be included only after consultation with&#xD;
               the Study Physician.&#xD;
  &#xD;
            9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of&#xD;
               radiation within 4 weeks of the first dose of study drug&#xD;
  &#xD;
           10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the&#xD;
               first dose of Investigational Product (IP). Note: Local surgery of isolated lesions&#xD;
               for palliative intent is acceptable&#xD;
  &#xD;
           11. Active or prior documented autoimmune or inflammatory disorders (including&#xD;
               inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with&#xD;
               the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,&#xD;
               or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid&#xD;
               arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this&#xD;
               criterion:&#xD;
  &#xD;
                 -  Patients with vitiligo or alopecia&#xD;
  &#xD;
                 -  Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on&#xD;
                    hormone replacement&#xD;
  &#xD;
                 -  Any chronic skin condition that does not require systemic therapy&#xD;
  &#xD;
                 -  Patients without active disease in the last 5 years may be included but only&#xD;
                    after consultation with the study physician&#xD;
  &#xD;
                 -  Patients with celiac disease controlled by diet alone&#xD;
  &#xD;
           12. History of leptomeningeal carcinomatosis&#xD;
  &#xD;
           13. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms&#xD;
               calculated from 3 ECGs (within 15 minutes at 5 minutes apart)&#xD;
  &#xD;
           14. Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical&#xD;
               study regardless of treatment arm assignment.&#xD;
  &#xD;
           15. Patients with an active autoimmune disease that has required systemic treatment in the&#xD;
               past 2 years with the use of disease-modifying agents, corticosteroids, or&#xD;
               immunosuppressive drugs. Exceptions to this criterion include intranasal, inhaled,&#xD;
               topical steroids or local steroid injections, systemic corticosteroids at physiologic&#xD;
               doses not to exceed 10mg/day or prednisone or its equivalent, or steroids as&#xD;
               premedication for hypersensitivity reactions.&#xD;
  &#xD;
           16. Patients with a history of allogenic organ transplantation.&#xD;
  &#xD;
           17. Patients with a history of non-infectious pneumonitis that required steroids or has&#xD;
               current pneumonitis.&#xD;
  &#xD;
           18. Patients who are recipients of a live attenuated vaccine within 30 days prior to the&#xD;
               dose of durvalumab.&#xD;
  &#xD;
           19. Patients with poorly controlled diarrhea (grade ≥ 2).&#xD;
  &#xD;
           20. Coinfection of hepatitis B virus (HBV) and hepatitis C virus (HCV) as determined by&#xD;
               viral load. HBV infection is allowed only if patient is on HBV treatment per&#xD;
               institutional guideline. HCV infection is allowed.&#xD;
  &#xD;
           21. Patients known to have tested positive for human immunodeficiency virus (HIV)&#xD;
               (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation&#xD;
               that may include clinical history, physical examination and radiographic findings, or&#xD;
               tuberculosis testing in line with local practice)&#xD;
  &#xD;
           22. Patients with a serious, non-stabilized disease, active uncontrolled infection, or&#xD;
               other serious underlying disorders that would likely prevent the patient from&#xD;
               receiving therapy.&#xD;
  &#xD;
           23. Patients who are pregnant, breast-feeding, or of child-bearing age with a refusal to&#xD;
               use effective contraception.&#xD;
  &#xD;
           24. Patients with another cancer, active within the 5 years preceding or at the time of&#xD;
               inclusion in this trial. Note: Patients with early-stage cancer that has been&#xD;
               resected/ablated/radiated, without evidence of disease recurrence or progression,&#xD;
               within 2 years may be considered.&#xD;
  &#xD;
           25. Patients with legal incapacity.&#xD;
  &#xD;
           26. Patients who are deprived of civil liberty.&#xD;
  &#xD;
           27. Patients for whom it is impossible to sign the informed consent document or to adhere&#xD;
               to medical follow-up of the trial for geographical, social, or psychological reasons.&#xD;
  &#xD;
           28. Patients who have participation in another clinical study with an investigational&#xD;
               product during the last 4 weeks.&#xD;
  &#xD;
           29. Patients who are concurrently enrolled in another clinical study, unless it is an&#xD;
               observational (non-interventional) clinical study or during the follow-up period of an&#xD;
               interventional study.&#xD;
  &#xD;
           30. Patients who are judged by the investigator that the patient is unsuitable to&#xD;
               participate in the study and the patient is unlikely to comply with the study&#xD;
               procedures, restrictions and requirements.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aiwu R He, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Georgetown University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aiwu He, MD</last_name>
      <phone>202-444-2223</phone>
      <email>ns1209@georgetown.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Lombardi Comprehensive Cancer Center, Georgetown University</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20007</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicole Swanson</last_name>
        <phone>202-687-9194</phone>
        <email>ns1209@georgetown.edu</email>
      </contact>
      <investigator>
        <last_name>Aiwu He, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholangiocarcinoma</mesh_term>
      <mesh_term>Biliary Tract Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gemcitabine</mesh_term>
      <mesh_term>Durvalumab</mesh_term>
      <mesh_term>Tremelimumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017297
  org study id: STUDY00006462
  nct id: NCT06017297
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to test feasibility and safety of the combination of
        tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge
        patients to a curative resection in treatment naïve borderline resectable, or resectable with
        high risk for recurrence intrahepatic cholangiocarcinoma patients. The main question[s] it
        aims to answer are:
  
          -  What is the rate of conversion of unresectable tumor to resectable cancer?
  
          -  What are the side effects of this treatment combination?
  
        Participants will undergo an initial tumor biopsy, imaging and laboratory studies prior to
        starting treatment with durvalumab, tremelimumab, gemcitabine and cisplatin. Participants
        will continue for 4 cycles and if the tumor is found to be resectable then they will undergo
        surgical resection. If the tumor is unresectable (can't be surgically removed) after 4
        cycles, then participants will receive 4 more cycles and repeated imaging. If the tumor
        remains unresectable then the participant will be treated with capecitabine for up to 8
        cycles and durvalumab for up to 12 months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of Conversion from unresectable to resectable
  time frame: 8 Cycles, 21 day cycles
  description: Rate of conversion of unresectable tumor to resectable cancer after neoadjuvant durvalumab + tremelimumab + gemcitabine + cisplatin after 4 or 8 cycles. Surgical evaluation will be done in joint by institutional radiology and hepatobiliary surgery using clinical data (CT/MRI imaging, patient performance status, labs, etc.) If among the evaluable 24 patients, 9 or more (45%) patients undergo such conversion, the investigational treatment will be considered as promising/feasible. The resectable rate will be estimated with its 95% exact confidence interval.
  measure: Incidence of related treatment emergent adverse events
  time frame: 36 months
  description: Number of participants with related treatment emergent adverse events
  measure: Objective Response Rate (ORR)
  time frame: 36 months
  description: ORR will be estimated with its 95% exact confidence interval based on RECIST v1.1
  measure: Pathological complete response (pCR)
  time frame: 36 months
  measure: Overall survival (OS)
  time frame: 36 months
  description: Kaplan-Meier method is used to represent secondary outcome OS.
  measure: Progression-free survival (PFS)
  time frame: 36 months
  description: Kaplan-Meier method is used to represent secondary outcome of PFS
  measure: Rate of R0 resection
  time frame: 8 Cycles, 21 day cycles
  description: R0 resection rate will be estimated with its 95% exact confidence interval
  measure: Relapse free survival (RFS)
  time frame: 36 months
  description: Kaplan-Meier method will be used to analyze RFS
  measure: Patient Reported outcomes (PRO) decline
  time frame: 8 Cycles, 21 day cycles
  description: As measured by qualify of life changes per EORTC QLQ-BIL-20 questionnaires. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
  measure: Event Free Survival (EFS)
  time frame: 36 months
  arm group label: Durvalumab and Tremelimumab plus gemcitabine/cisplatin
  arm group type: Experimental
  description: Durvalumab and tremelimumab plus gemcitabine/cisplatin combination therapy. If the tumor is evaluated to be resectable after Cycle 4 (C4), then the patient may proceed with surgical tumor resection. If the tumor is deemed unresectable after C4, then the patient will proceed with Cycle 5-8 followed by reevaluation for surgical resection.
  intervention type: Drug
  intervention name: Durvalumab
  description: Durvalumab 1500 mg via intravenous (IV) infusion every 3 weeks for up to 8 cycles
  arm group label: Durvalumab and Tremelimumab plus gemcitabine/cisplatin
  intervention type: Drug
  intervention name: Tremelimumab
  description: A single dose of tremelimumab at 300mg IV is given on C1.
  arm group label: Durvalumab and Tremelimumab plus gemcitabine/cisplatin
  intervention type: Drug
  intervention name: Gemcitabine
  description: Gemcitabine is dosed at 1000 mg/m2 IV on day (D)1 and D8 of each cycle.
  arm group label: Durvalumab and Tremelimumab plus gemcitabine/cisplatin
  intervention type: Drug
  intervention name: Cisplatin
  description: Cisplatin is dosed at 25mg/m2 on D1 and D8 of each cycle.
  arm group label: Durvalumab and Tremelimumab plus gemcitabine/cisplatin
  intervention type: Procedure
  intervention name: Surgical Resection
  description: If the tumor is evaluated to be resectable (as defined as successfully treated stage II (tumor shrink away from vessels), stage IIIA (tumor shrink away from visceral peritoneum), stage IIIB (N1 disease no longer pathologically enlarged) after C4 or C8, then the patient may proceed with surgical tumor resection.
  arm group label: Durvalumab and Tremelimumab plus gemcitabine/cisplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aiwu R He, MD
  role: Principal Investigator
  affiliation: Georgetown University
  last name: Aiwu He, MD
  phone: 202-444-2223
  email: ns1209@georgetown.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cholangiocarcinoma
  mesh term: Biliary Tract Neoplasms
  mesh term: Gemcitabine
  mesh term: Durvalumab
  mesh term: Tremelimumab
  sharing ipd: No