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A Study for PD-1 Antibody JS001 in MSI-H Advanced or Recurrent Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118933
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

Brief Summary:
To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker of PD-1/PD-L1 inhibitor.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: JS001 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study for PD-1 Antibody JS001 in Participants With Microsatellite Instability-high (MSI-H) Advanced or Recurrent Colorectal Cancer
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : July 17, 2021

Arm Intervention/treatment
Experimental: MSI-H advanced colorectal cancer Drug: JS001
JS001 240mg, Q3W




Primary Outcome Measures :
  1. objective response rate [ Time Frame: 12 Weeks from the drug firstly being taken ]
    The 12 week objective response will be measured according to RECIST v1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fully understand the study and sign informed consent voluntarily;
  • Histologically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H;
  • Patients who have previously received first-line or above chemotherapy or targeted therapy and failed to the treatment or experienced recurrence;
  • At least one measurable lesion (RECIST 1.1);
  • Agree to provide tumor tissue samples and Pathology reports related to the specimens;
  • Aged 18 to 75 years, gender not limited;
  • Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1; 8. Expected survival ≥3 months;
  • Laboratory test values must meet the following standards within 7 days before enrollment;
  • Women of reproductive age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study drug use

Exclusion Criteria:

  • Uncontrolled or symptomatic hypercalcemia;
  • Had major surgery or had not fully recovered from previous surgery within 4 weeks before enrollment;
  • central nervous system(CNS) metastases;
  • Bone metastases;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allow the patient to have a catheter indwelling;
  • Having a history of idiopathic pulmonary fibrosis, organic pneumonia;
  • Uncontrolled active infection, including but not limited to acute pneumonia;
  • Have other malignant tumors at the same time;
  • The patient has any active autoimmune diseases or a history of autoimmune diseases;
  • Liver diseases of known clinical significance, including active viral viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, fatty liver and hereditary liver diseases.
  • Previous use of anti-PD-1 antibody, anti-PD-l1 antibody, anti-PD-l2 antibody or anti-CTLA-4 antibody;
  • Patients with active tuberculosis (TB);
  • Received systemic immunosuppressive within 4 weeks prior to day 1 of the first cycle;
  • Pregnancy test positive;
  • Known human immunodeficiency virus (HIV) infection;
  • A history of severe allergy, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
  • Those who are known to be allergic to biological drugs produced by hamster ovary cells in China, or to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbate (components of the experimental drugs);
  • Patients who have previously received allogeneic stem cells or parenchymal organ transplantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118933


Contacts
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Contact: Jianmin Xu, MD +8613501984869 xujmin@aliyun.com

Locations
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China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Dexiang Zhu, MD    +8613764353275    shzhudx@163.com   
Sponsors and Collaborators
Xu jianmin
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Responsible Party: Xu jianmin, Deputy director of the colorectal cancer center, Fudan University
ClinicalTrials.gov Identifier: NCT04118933    
Other Study ID Numbers: K19406-JS001-ISS-141
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases