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RECRUITING
NCT07896681
PHASE2

Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This phase II, single-arm clinical study aims to evaluate the efficacy and safety of toripalimab combined with cetuximab and irinotecan as second-line treatment for patients with advanced right-sided colon cancer with wild-type RAS and BRAF genes. The study will enroll up to 46 adult patients with recurrent or metastatic right-sided colon cancer whose disease has progressed after first-line systemic therapy. Eligible patients must have wild-type RAS and BRAF genes and must not have previously received anti-EGFR antibodies or irinotecan. All participants will receive toripalimab, cetuximab, and irinotecan by intravenous infusion every two weeks. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation. The primary outcome is the objective response rate (ORR), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary outcomes include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment safety. Exploratory analyses will investigate potential biomarkers associated with treatment response using blood, tumor tissue, and other biological samples. This study seeks to generate clinical evidence regarding the potential efficacy and safety of this combination therapy in patients with advanced right-sided colon cancer who require second-line treatment.

Official title: A Phase II Study of Toripalimab in Combination With Cetuximab and Irinotecan as Second-Line Treatment for Patients With Advanced Right-Sided RAS/BRAF Wild-Type Colon Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-07-03

Completion Date

2028-09-01

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

Toripalimab

Toripalimab will be administered intravenously at a dose of 3 mg/kg every 2 weeks. The first infusion will last at least 60 minutes. Subsequent infusions may be shortened to at least 30 minutes if tolerated. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.

DRUG

Cetuximab

Cetuximab will be administered intravenously at a dose of 500 mg/m² every 2 weeks in combination with toripalimab and irinotecan. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.

DRUG

Irinotecan

Irinotecan will be administered intravenously at a dose of 180 mg/m² every 2 weeks in combination with toripalimab and cetuximab. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.

Locations (1)

National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China