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/NCT05967182</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1003</org_study_id>
      <secondary_id>NCI-2023-05889</secondary_id>
      <nct_id>NCT05967182</nct_id>
    </id_info>
    <brief_title>A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma</brief_title>
    <official_title>A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>M.D. Anderson Cancer Center</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and&#xD;
        gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after&#xD;
        surgery, compared to treatment with surgery and standard chemotherapy alone.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objectives and Endpoints:&#xD;
  &#xD;
          -  To evaluate RFS. RFS will be defined as time from curative-intent surgery to disease&#xD;
             recurrence. Median, 9-month, and 12-month RFS rates will be measured.&#xD;
  &#xD;
          -  To evaluate the rate of major pathologic response. Pathologic response will be assessed&#xD;
             both by determining the percentage of the bulk tumor made up of viable cancer cells,&#xD;
             with &lt; 10% signifying a major pathologic response, and by evaluating indicators of&#xD;
             immune-mediated pathologic response which incorporate elements of tumor necrosis and&#xD;
             fibroinflammatory stroma.&#xD;
  &#xD;
        Primary Endpoints: RFS rate, major pathologic response rate&#xD;
  &#xD;
        Secondary Objectives and Endpoints:&#xD;
  &#xD;
        Objectives: To assess safety and other markers of efficacy, including objective response rate&#xD;
        (ORR) and overall survival (OS).&#xD;
  &#xD;
        Secondary Endpoints:&#xD;
  &#xD;
          -  To evaluate the safety and efficacy of pembrolizumab in combination with gemcitabine and&#xD;
             cisplatin&#xD;
  &#xD;
          -  Safety profile per CTCAE v5.0, including term, incidence, severity, and duration of AEs&#xD;
  &#xD;
          -  Objective response rate (ORR) by RECIST 1.1 criteria&#xD;
  &#xD;
          -  12- and 24-month overall survival (OS) by RECIST 1.1 criteria&#xD;
  &#xD;
          -  Median progression free survival (PFS) and median overall survival (OS) according to&#xD;
             RECIST v1.1&#xD;
  &#xD;
        Exploratory Objectives and Endpoints:&#xD;
  &#xD;
          -  Correlative studies will be performed to assess the immunologic response to neoadjuvant&#xD;
             pembrolizumab with gemcitabine and cisplatin including but not limited to blood and&#xD;
             tissue-based biomarkers, gene alterations, immunologic markers and pharmacodynamic&#xD;
             markers from study treatment.&#xD;
  &#xD;
          -  To assess and correlate gut microbiome diversity, composition, structure, and functional&#xD;
             characteristics pre- and post-NAT.&#xD;
  &#xD;
          -  To assess the biliary microbiome diversity, composition and functional characteristics&#xD;
             (if bile is able to be collected at the time of surgery), and to compare the biliary&#xD;
             microbiome to pre- and post-NAT gut microbiome, as well as to clinicopathologic&#xD;
             outcomes.&#xD;
  &#xD;
          -  To evaluate the effects of pembrolizumab on pharmacodynamic markers: ctDNA, tissue&#xD;
             biopsies, and/or blood to assess biomarkers. include, but are not limited to,&#xD;
             circulating tumor DNA and exosome analyses, gene expression studies, reverse phase&#xD;
             protein arrays (RPPA, and Nanostring and/or RNA-exome to assess mRNA expression.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 31, 2024</start_date>
    <completion_date type="Anticipated">July 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</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>Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0</measure>
      <time_frame>through study completion; an average of 1 year</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Cholangiocarcinoma</condition>
    <arm_group>
      <arm_group_label>Pembrolizumab with Gemcitabine and Cisplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 4 cycles (21 days each) of the combined chemotherapy before and after your scheduled surgery. During the 9 months of chemotherapy treatment, participants will have clinic visits every 3 weeks or so. During the 2-4 year follow-up period, participants will come to the clinic every 3 months or so</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab</intervention_name>
      <description>Given by IV (vein)</description>
      <arm_group_label>Pembrolizumab with Gemcitabine and Cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>Given by IV (vein)</description>
      <arm_group_label>Pembrolizumab with Gemcitabine and Cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Given by IV (vein)</description>
      <arm_group_label>Pembrolizumab with Gemcitabine and Cisplatin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Participants are eligible to be included in the study only if all of the following criteria&#xD;
          apply:&#xD;
  &#xD;
            1. Provision of signed Informed Consent prior to any screening procedures being&#xD;
               performed.&#xD;
  &#xD;
            2. Age ≥ 18 years at the time of informed consent.&#xD;
  &#xD;
            3. Histologically (or cytologically) confirmed diagnosis of intrahepatic&#xD;
               cholangiocarcinoma or adenocarcinoma of suspected biliary origin/ cholangiocarcinoma&#xD;
               that is measurable according to RECIST 1.1 criteria.&#xD;
  &#xD;
               a) Lesions situated in a previously irradiated area are considered measurable if&#xD;
               progression has been demonstrated in such lesions.&#xD;
  &#xD;
            4. Has high-risk, but resectable, ICC confined to the liver, bile duct, and /or regional&#xD;
               lymph nodes. Tumors will be considered high-risk if the high-quality,&#xD;
               contrast-enhanced CT and/or MRI +/- positron emission tomography (PET) scan done&#xD;
               within 6 weeks of screening show at least one of the following (a-e):&#xD;
  &#xD;
                 1. T-stage ≥ Ib (Ib - IIIb)&#xD;
  &#xD;
                 2. Solitary lesion &gt; 5 cm&#xD;
  &#xD;
                 3. Multifocal tumors or satellite lesions present confined to the same lobe of the&#xD;
                    liver as the dominant lesion but still technically resectable&#xD;
  &#xD;
                 4. Presence of major vascular invasion but still technically resectable&#xD;
  &#xD;
                 5. Suspicious or involved regional lymph nodes (N1)&#xD;
  &#xD;
                 6. Serum CA 19-9 &gt; 200 U/mL&#xD;
  &#xD;
            5. ECOG performance status of 0-1.&#xD;
  &#xD;
            6. Adequate hematologic status: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Hemoglobin&#xD;
               (Hgb) ≥ 9 g/dL with or without transfusions; Platelets (PLT) ≥ 100 x 109/L without&#xD;
               transfusions.&#xD;
  &#xD;
            7. Adequate liver function:&#xD;
  &#xD;
                 1. ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases&#xD;
  &#xD;
                 2. Total bilirubin ≤ 1.5 × ULN and &lt; 2 mg/dL i. Note: Patients who have a total&#xD;
                    bilirubin level &gt; 1.5 x ULN will be allowed if their indirect bilirubin level is&#xD;
                    ≤ 1.5 x ULN ii. Note: Participants with hyperbilirubinemia due to non-hepatic&#xD;
                    cause (e.g., hemolysis, hematoma) may be enrolled following discussion and&#xD;
                    agreement with the principle investigator&#xD;
  &#xD;
                 3. International normalized ratio (INR), prothrombin time (PT), Activated partial&#xD;
                    thromboplastin time (aPTT): ≤1.5 × ULN unless participant is receiving&#xD;
                    anticoagulant therapy as long as PT or aPTT is within therapeutic range of&#xD;
                    intended use of anticoagulants&#xD;
  &#xD;
            8. Adequate renal function: Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine&#xD;
               clearance (determined as per Cockcroft-Gault) ≥ 50mL/min at screening.&#xD;
  &#xD;
            9. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral&#xD;
               load must be undetectable on suppressive therapy, if indicated.&#xD;
  &#xD;
           10. Patients with a history of hepatitis C virus (HCV) infection must have been treated&#xD;
               and cured. For patients with HCV infection who are currently on treatment, they are&#xD;
               eligible if they have an undetectable HCV viral load.&#xD;
  &#xD;
           11. Willing and able to participate in the trial and comply with all trial requirements.&#xD;
  &#xD;
           12. Patients with a prior or concurrent malignancy whose natural history or treatment does&#xD;
               not have the potential to interfere with the safety or efficacy assessment of the&#xD;
               investigational agent may be included after consultation with the medical monitor.&#xD;
  &#xD;
           13. The effects of pembrolizumab in combination with gemcitabine and cisplatin on the&#xD;
               developing human fetus are unknown. For this reason and because gemcitabine and&#xD;
               cisplatin used in this trial are known to be teratogenic, women of child-bearing&#xD;
               potential and men must agree to use adequate contraception (hormonal or barrier method&#xD;
               of birth control; abstinence) prior to study entry and for the duration of study&#xD;
               participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy&#xD;
               # CLN1114). This includes all female patients, between the onset of menses (as early&#xD;
               as 8 years of age) and 55 years unless the patient presents with an applicable&#xD;
               exclusionary factor which may be one of the following:&#xD;
  &#xD;
                 -  Postmenopausal (no menses in greater than or equal to 12 consecutive months).&#xD;
  &#xD;
                 -  History of hysterectomy or bilateral salpingo-oophorectomy.&#xD;
  &#xD;
                 -  Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range,&#xD;
                    who have received Whole Pelvic Radiation Therapy).&#xD;
  &#xD;
                 -  History of bilateral tubal ligation or another surgical sterilization procedure.&#xD;
  &#xD;
                 -  Approved methods of birth control are as follows: Hormonal contraception (i.e.&#xD;
                    birth control pills, injection, implant, transdermal patch, vaginal ring),&#xD;
                    Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post&#xD;
                    vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide.&#xD;
                    Not engaging in sexual activity for the total duration of the trial and the drug&#xD;
                    washout period is an acceptable practice; however periodic abstinence, the rhythm&#xD;
                    method, and the withdrawal method are not acceptable methods of birth control.&#xD;
                    Should a woman become pregnant or suspect she is pregnant while she or her&#xD;
                    partner is participating in this study, she should inform her treating physician&#xD;
                    immediately.&#xD;
  &#xD;
                 -  Men treated or enrolled on this protocol must also agree to use adequate&#xD;
                    contraception prior to the study for the duration of study participation, and 4&#xD;
                    months after completion of treatment administration.&#xD;
  &#xD;
           14. Ability to understand and the willingness to sign a written informed consent document.&#xD;
  &#xD;
           15. English and non-English-speaking patients.&#xD;
  &#xD;
           16. Patients with HIV on effective anti-retroviral therapy with undetectable viral load&#xD;
               and CD4 count &gt; 100 cells/µL within 6 months are eligible for this trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants are excluded from the study if any of the following criteria apply:&#xD;
  &#xD;
            1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an&#xD;
               agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4,&#xD;
               OX40, CD137).&#xD;
  &#xD;
            2. Has had previous systemic therapy for ICC.&#xD;
  &#xD;
            3. Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology&#xD;
               and/or mucinous cystic neoplasm.&#xD;
  &#xD;
            4. Has received prior systemic anti-cancer therapy including investigational agents&#xD;
               within 4 weeks prior to allocation.&#xD;
  &#xD;
            5. Uncontrolled intercurrent illness including symptomatic congestive heart failure,&#xD;
               unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3&#xD;
               months of initiation of therapy.&#xD;
  &#xD;
            6. Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic&#xD;
               therapy.&#xD;
  &#xD;
            7. Has received prior radiotherapy within 2 weeks of start of study intervention.&#xD;
               Participants must have recovered from all radiation-related toxicities, not require&#xD;
               corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted&#xD;
               for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.&#xD;
  &#xD;
            8. Has received a live vaccine or live-attenuated vaccine within 30 days before the first&#xD;
               dose of study intervention. Administration of killed vaccines is allowed.&#xD;
  &#xD;
            9. Is currently participating in or has participated in a study of an investigational&#xD;
               agent or has used an investigational device within 4 weeks prior to the first dose of&#xD;
               study intervention.&#xD;
  &#xD;
           10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
               (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of&#xD;
               immunosuppressive therapy within 7 days prior to the first dose of study drug.&#xD;
  &#xD;
           11. Known additional malignancy that is progressing or has required active treatment&#xD;
               within the past 2 years. Note: Participants with basal cell carcinoma of the skin,&#xD;
               squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ&#xD;
               of the bladder, that have undergone potentially curative therapy are not excluded.&#xD;
  &#xD;
           12. Has known active CNS metastases and/or carcinomatous meningitis. Participants with&#xD;
               previously treated brain metastases may participate provided they are radiologically&#xD;
               stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging&#xD;
               (note that the repeat imaging should be performed during study screening), clinically&#xD;
               stable and without requirement of steroid treatment for at least 14 days prior to&#xD;
               first dose of study intervention.&#xD;
  &#xD;
           13. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.&#xD;
  &#xD;
           14. Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
               (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
               drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid&#xD;
               replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
               form of systemic treatment and is allowed.&#xD;
  &#xD;
           15. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required&#xD;
               steroids or has current pneumonitis/interstitial lung disease.&#xD;
  &#xD;
           16. Has an active infection requiring systemic therapy.&#xD;
  &#xD;
           17. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA)&#xD;
               and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA)&#xD;
               infection.&#xD;
  &#xD;
               Note: Hepatitis B and C screening tests are not required unless:&#xD;
  &#xD;
                 -  Known history of HBV and HCV infection&#xD;
  &#xD;
                 -  As mandated by local health authority&#xD;
  &#xD;
           18. Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
               or other circumstance that might confound the results of the study, interfere with the&#xD;
               participant's participation for the full duration of the study, such that it is not in&#xD;
               the best interest of the participant to participate, in the opinion of the treating&#xD;
               investigator.&#xD;
  &#xD;
           19. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
               cooperation with the requirements of the trial, as determined by the treating&#xD;
               investigator.&#xD;
  &#xD;
           20. Is pregnant or breastfeeding or expecting to conceive or father children within the&#xD;
               projected duration of the study, starting with the screening visit through 120 days&#xD;
               after the last dose of trial treatment.&#xD;
  &#xD;
           21. Has had an allogenic tissue/solid organ transplant.&#xD;
  &#xD;
           22. Cognitive impairment.&#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>Hop Tran Cao, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D. Anderson Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hop Tran Cao, MD</last_name>
      <phone>(713) 745-4670</phone>
      <email>hstran@mdanderson.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>M D Anderson Cancer Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Hop Tran Cao, MD</last_name>
        <phone>713-745-4670</phone>
        <email>hstran@mdanderson.org</email>
      </contact>
      <investigator>
        <last_name>Hop Tran Cao, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mdanderson.org</url>
      <description>M D Anderson Cancer Center</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gemcitabine</mesh_term>
      <mesh_term>Pembrolizumab</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05967182
  org study id: 2022-1003
  secondary id: NCI-2023-05889
  nct id: NCT05967182
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and
        gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after
        surgery, compared to treatment with surgery and standard chemotherapy alone.
  Primary Objectives and Endpoints:
  
          -  To evaluate RFS. RFS will be defined as time from curative-intent surgery to disease
             recurrence. Median, 9-month, and 12-month RFS rates will be measured.
  
          -  To evaluate the rate of major pathologic response. Pathologic response will be assessed
             both by determining the percentage of the bulk tumor made up of viable cancer cells,
             with < 10% signifying a major pathologic response, and by evaluating indicators of
             immune-mediated pathologic response which incorporate elements of tumor necrosis and
             fibroinflammatory stroma.
  
        Primary Endpoints: RFS rate, major pathologic response rate
  
        Secondary Objectives and Endpoints:
  
        Objectives: To assess safety and other markers of efficacy, including objective response rate
        (ORR) and overall survival (OS).
  
        Secondary Endpoints:
  
          -  To evaluate the safety and efficacy of pembrolizumab in combination with gemcitabine and
             cisplatin
  
          -  Safety profile per CTCAE v5.0, including term, incidence, severity, and duration of AEs
  
          -  Objective response rate (ORR) by RECIST 1.1 criteria
  
          -  12- and 24-month overall survival (OS) by RECIST 1.1 criteria
  
          -  Median progression free survival (PFS) and median overall survival (OS) according to
             RECIST v1.1
  
        Exploratory Objectives and Endpoints:
  
          -  Correlative studies will be performed to assess the immunologic response to neoadjuvant
             pembrolizumab with gemcitabine and cisplatin including but not limited to blood and
             tissue-based biomarkers, gene alterations, immunologic markers and pharmacodynamic
             markers from study treatment.
  
          -  To assess and correlate gut microbiome diversity, composition, structure, and functional
             characteristics pre- and post-NAT.
  
          -  To assess the biliary microbiome diversity, composition and functional characteristics
             (if bile is able to be collected at the time of surgery), and to compare the biliary
             microbiome to pre- and post-NAT gut microbiome, as well as to clinicopathologic
             outcomes.
  
          -  To evaluate the effects of pembrolizumab on pharmacodynamic markers: ctDNA, tissue
             biopsies, and/or blood to assess biomarkers. include, but are not limited to,
             circulating tumor DNA and exosome analyses, gene expression studies, reverse phase
             protein arrays (RPPA, and Nanostring and/or RNA-exome to assess mRNA expression.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
  time frame: through study completion; an average of 1 year
  arm group label: Pembrolizumab with Gemcitabine and Cisplatin
  arm group type: Experimental
  description: Participants will receive 4 cycles (21 days each) of the combined chemotherapy before and after your scheduled surgery. During the 9 months of chemotherapy treatment, participants will have clinic visits every 3 weeks or so. During the 2-4 year follow-up period, participants will come to the clinic every 3 months or so
  intervention type: Drug
  intervention name: Pembrolizumab
  description: Given by IV (vein)
  arm group label: Pembrolizumab with Gemcitabine and Cisplatin
  intervention type: Drug
  intervention name: Gemcitabine
  description: Given by IV (vein)
  arm group label: Pembrolizumab with Gemcitabine and Cisplatin
  intervention type: Drug
  intervention name: Cisplatin
  description: Given by IV (vein)
  arm group label: Pembrolizumab with Gemcitabine and Cisplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hop Tran Cao, MD
  role: Principal Investigator
  affiliation: M.D. Anderson Cancer Center
  last name: Hop Tran Cao, MD
  phone: (713) 745-4670
  email: hstran@mdanderson.org
  facility: 
  contact: 
  investigator: 
  country: United States
  url: http://www.mdanderson.org
  description: M D Anderson Cancer Center
  responsible party type: Sponsor
  mesh term: Cholangiocarcinoma
  mesh term: Gemcitabine
  mesh term: Pembrolizumab