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RECRUITING
NCT03985891
PHASE1/PHASE2

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

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-12-16

Completion Date

2026-06-01

Last Updated

2020-12-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Shan Zeng

Changsha, Hunan, China