drugset / Trial / NCT03985891

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

NCT03985891

Phase 1/2 Unknown 40 enrolled Xiangya Hospital of Central South University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2020-12-16
Primary completion
2025-06-01
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 3 mg/kg
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 1200 mg/m2 Intravenous