RecruitingPhase 1Phase 2NCT03985891

The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer

A Randomized, Prospective Clinical Trial of Safety and Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer (Perioperative Treatment)


Sponsor

Xiangya Hospital of Central South University

Enrollment

40 participants

Start Date

Dec 16, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/neoadjuvant treatment for patients with locally advanced colon cancer.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study combines the immunotherapy drug JS001 (an anti-PD-1 drug similar to pembrolizumab) with chemotherapy before surgery in patients with locally advanced colon cancer. The goal is to shrink the tumor enough to allow surgical removal. **You may be eligible if...** - You are 18 or older - You have locally advanced colon cancer confirmed by biopsy - Your cancer team has decided that pre-surgical (neoadjuvant) chemotherapy is appropriate - You have at least one measurable tumor on scans - Your ECOG score is 0-1 (able to perform normal daily activities) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have metastatic (widely spread) cancer - Your blood counts or organ function are outside acceptable limits - Your overall health level is too poor (ECOG 2 or above) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAnti-PD-1 Monoclonal Antibody JS001

Anti-PD-1 monoclonal antibody combined with chemotherapy in patients with locally advanced colon cancer (perioperative treatment)

DRUGChemotherapy

Folfox


Locations(1)

Shan Zeng

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03985891


Related Trials