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

NCT04118933 | Unknown Phase 2

• 1 other identifier: K19406-JS001-ISS-141
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  The 12 week objective response will be measured according to RECIST v1.1

  12 Weeks from the drug firstly being taken

Study Arms (1)

MSI-H advanced colorectal cancer

EXPERIMENTAL

Drug: JS001

Interventions

JS001 DRUG

JS001 240mg, Q3W

MSI-H advanced colorectal cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xu jianmin: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jianmin Xu, MD

CONTACT

+8613501984869; xujmin@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director of the colorectal cancer center

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 8, 2019
• Study Start: July 17, 2019
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2021
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

CN (1)