NCT03985891

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 and it can improve the R0 resection rate, as well as reduce recurrence rate, but the overall responding rate is limited. Currently, immune checkpoint blocked (ICB) emerges as a promising approach in early colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA in melanoma. This study was designed as a prospective, randomized, controlled trial. Patients who meet the enrollment criteria will receive FOLFOX (Q2W) and JS001 (3mg/kg, Q2W) or only FOLFOX for neoadjuvant treatment 6 cycles in pre-operation and same treatment after operation, a total of six months. The assessment will be conducted in the 6th week and 13th week from the initiation date in the first cycle. The patients will be followed up for 5 years. The pCR rate, rCR rate, ORR, DFS, OS and Safety will be compared. 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.

Conditions

• Colonic Neoplasms
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Anti-PD-1 Monoclonal Antibody JS001	Anti-PD-1 monoclonal antibody combined with chemotherapy in patients with locally advanced colon cancer (perioperative treatment)
DRUG	Chemotherapy	Folfox

Timeline

• Start date: 2020-12-16
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2019-06-14
• Last updated: 2020-12-17

Locations

1 site across 1 country: China