<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/NCT04446091</url>
  </required_header>
  <id_info>
    <org_study_id>ChiECRCT20200108</org_study_id>
    <nct_id>NCT04446091</nct_id>
  </id_info>
  <brief_title>A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)</brief_title>
  <official_title>A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single center, non-randomized, phase Ⅱ trial to evaluate safety and&#xD;
      efficacy of using the combination treatment of Camrelizumab with anti-angiogenic drugs and&#xD;
      Chemotherapy of metastatic colorectal mucinous adenocarcinoma(MAC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer contains multiple pathological types, and one of the more special&#xD;
      pathological types is mucinous adenocarcinoma. The prognosis of patients with mucinous&#xD;
      adenocarcinoma is not ideal.Some molecular and genetic factors may be related to the&#xD;
      characteristics of mucinous adenocarcinoma, in which microsatellite instability and loss of&#xD;
      mismatch repair proteins are a focus of current research. Microsatellite instability is often&#xD;
      associated with poor differentiation and higher tumor stage. Adenocarcinoma that secretes a&#xD;
      large amount of mucus in pathological features.so,In this study, the incidence of ORR and AEs&#xD;
      was the main endpoint, and the efficacy and safety of Camrelizumab combined with&#xD;
      anti-angiogenic drugs in the treatment of advanced colorectal mucinous adenocarcinoma were&#xD;
      observed and evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR：Objective Response Rate</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DCR: disease control rate</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>partial rate of subjects evaluated as CR/PR/SD in all subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS: progression-free survival</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>time from randomization to progression and death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS: overall survival</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>time from randomization to death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Two-drug group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Camrelizumab:200mg,iv,Q2W; Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Three-drug group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Camrelizumab:200mg,iv,Q3W; Irinotecan:150mg/m2,iv 30~90min,d1,Q3W Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)</intervention_name>
    <description>Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs for colorectal mucinous adenocarcinoma</description>
    <arm_group_label>Two-drug group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan</intervention_name>
    <description>Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs and chemotherapy for colorectal mucinous adenocarcinoma</description>
    <arm_group_label>Three-drug group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Join the study voluntarily and sign the informed consent;&#xD;
&#xD;
          -  2. Unresectable locally advanced or metastatic colorectal mucinous adenocarcinoma or&#xD;
             colorectal adenocarcinoma containing mucinous gland components diagnosed by&#xD;
             histopathology or cytology;&#xD;
&#xD;
          -  3. Patients who have received at least first-line and above systemic chemotherapy&#xD;
             (which may include platinum, fluorouracil, or irinotecan-based) progress or&#xD;
             intolerance (maintenance treatment progress after first-line chemotherapy can also be&#xD;
             included). Simultaneous chemoradiotherapy for recurrence or metastasis after surgery&#xD;
             is considered as first-line treatment; for radical concurrent chemoradiotherapy,&#xD;
             neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if disease&#xD;
             progression occurs during treatment or within 6 months after stopping treatment, It&#xD;
             should be counted as a failure of first-line treatment;&#xD;
&#xD;
          -  4. Age 18-75 years old (including boundary value, calculated on the day of signing&#xD;
             informed consent), both men and women;&#xD;
&#xD;
          -  5. ECOG score 0-2 points;&#xD;
&#xD;
          -  6. Blood routine and liver and kidney function meet the following conditions:&#xD;
             neutrophil count&gt;1.5*10^9/L, hemoglobin concentration&gt;90g/L, platelet count&gt;80*109/L;&#xD;
             ALT and AST&lt;2.0*ULN (with liver The transferee may be &lt;5.0*ULN);&#xD;
&#xD;
          -  7. Estimated survival time&gt; 3 months;&#xD;
&#xD;
          -  8. Willing to accept long-term follow-up, willing to provide tumor tissue samples,&#xD;
             willing to provide blood samples before and after treatment;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Known predisposition of inherited or acquired bleeding and thrombosis (such as&#xD;
             hemophiliacs, coagulopathy, thrombocytopenia, etc.);&#xD;
&#xD;
          -  2. Urinary routines suggest that urine protein ≥ ++ and a confirmed 24-hour urine&#xD;
             protein amount&gt; 1.0 g;&#xD;
&#xD;
          -  3. Suffering from active infection, or unexplained fever within 7 days before&#xD;
             medication ≥ 38.5℃, or baseline white blood cell count&gt; 15×109/L;&#xD;
&#xD;
          -  4. There are contraindications for immunotherapy (including long-term use of hormones,&#xD;
             radiation pneumonia has not been cured and cured within 3 months, etc.);&#xD;
&#xD;
          -  5. Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring&#xD;
             hormone replacement therapy, etc.);&#xD;
&#xD;
          -  6. Patients with active hepatitis B or C, HIV patients, active tuberculosis, etc.;&#xD;
&#xD;
          -  7. Active infection requires antimicrobial treatment (for example, antibacterial&#xD;
             drugs, antiviral drugs, antifungal drugs);&#xD;
&#xD;
          -  8. Known history of allogeneic organ transplantation and history of transplanted&#xD;
             hematopoietic stem cells;&#xD;
&#xD;
          -  9. Patients with interstitial lung disease or previous history of interstitial&#xD;
             pneumonia;&#xD;
&#xD;
          -  10. Those who have a history of psychotropic substance abuse and are unable to quit or&#xD;
             have mental disorders;&#xD;
&#xD;
          -  11. Participated in clinical trials of other anti-tumor drugs within 2 weeks before&#xD;
             enrollment;&#xD;
&#xD;
          -  12. Those who have used PD-1/PD-L1 and other immunotherapy drugs before entering the&#xD;
             group;&#xD;
&#xD;
          -  13. Previous or concurrently suffering from other uncured malignant tumors, cured skin&#xD;
             basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer can&#xD;
             be included;&#xD;
&#xD;
          -  14. Pregnant or lactating women; those with fertility who are unwilling or unable to&#xD;
             take effective contraceptive measures;&#xD;
&#xD;
          -  15. According to the investigator's judgment, there are other factors that may affect&#xD;
             the results of the study or lead to the forced termination of the study, such as&#xD;
             alcoholism, drug abuse, other serious diseases (including mental illness) need to be&#xD;
             treated together, and there are serious laboratory abnormalities , Accompanied by&#xD;
             family or social factors, will affect the safety of the subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Luo Cong, Doctor of Oncology</last_name>
    <phone>13456711894</phone>
    <email>lw939291@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhejiang Province Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luo Cong, Doctor</last_name>
      <phone>13456711894</phone>
      <email>lw939291@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colorectal mucinous adenocarcinoma (MAC),Camrelizumab,PD-1,anti-angiogenic drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma, Mucinous</mesh_term>
    <mesh_term>Cystadenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Apatinib</mesh_term>
    <mesh_term>Angiogenesis Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04446091
org study id: ChiECRCT20200108
nct id: NCT04446091
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an open-label, single center, non-randomized, phase Ⅱ trial to evaluate safety and
      efficacy of using the combination treatment of Camrelizumab with anti-angiogenic drugs and
      Chemotherapy of metastatic colorectal mucinous adenocarcinoma(MAC).
Colorectal cancer contains multiple pathological types, and one of the more special
      pathological types is mucinous adenocarcinoma. The prognosis of patients with mucinous
      adenocarcinoma is not ideal.Some molecular and genetic factors may be related to the
      characteristics of mucinous adenocarcinoma, in which microsatellite instability and loss of
      mismatch repair proteins are a focus of current research. Microsatellite instability is often
      associated with poor differentiation and higher tumor stage. Adenocarcinoma that secretes a
      large amount of mucus in pathological features.so,In this study, the incidence of ORR and AEs
      was the main endpoint, and the efficacy and safety of Camrelizumab combined with
      anti-angiogenic drugs in the treatment of advanced colorectal mucinous adenocarcinoma were
      observed and evaluated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ORR：Objective Response Rate
time frame: through study completion, an average of 2 year
description: Objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1
measure: DCR: disease control rate
time frame: through study completion, an average of 2 year
description: partial rate of subjects evaluated as CR/PR/SD in all subjects
measure: PFS: progression-free survival
time frame: through study completion, an average of 2 year
description: time from randomization to progression and death
measure: OS: overall survival
time frame: through study completion, an average of 2 year
description: time from randomization to death
arm group label: Two-drug group
arm group type: Experimental
description: Camrelizumab:200mg,iv,Q2W; Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
arm group label: Three-drug group
arm group type: Experimental
description: Camrelizumab:200mg,iv,Q3W; Irinotecan:150mg/m2,iv 30~90min,d1,Q3W Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
intervention type: Drug
intervention name: Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)
description: Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs for colorectal mucinous adenocarcinoma
arm group label: Two-drug group
intervention type: Drug
intervention name: Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan
description: Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs and chemotherapy for colorectal mucinous adenocarcinoma
arm group label: Three-drug group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Luo Cong, Doctor of Oncology
phone: 13456711894
email: lw939291@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma, Mucinous
mesh term: Cystadenocarcinoma
mesh term: Irinotecan
mesh term: Apatinib
mesh term: Angiogenesis Inhibitors
sharing ipd: Undecided