Neoadjuvant Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 1, 2028

Study Completion Date

April 1, 2031

Conditions
Colorectal Cancer (CRC)PD-1 InhibitorNeoadjuvant ImmunotherapyCelecoxibWatch &Amp; Wait
Interventions
DRUG

Toripalimab combined with celecoxib

Toripalimab is administered via intravenous infusion at 3 mg/kg over 30 minutes (initial infusion time is 60 minutes), once every two weeks, for a total of 12 doses before surgery. Celecoxib is taken orally at 200 mg per dose, twice daily, for a duration of 6 months.

PROCEDURE

Curative resection of colorectal cancer

Patients who do not achieve cCR based on radiographic imaging (CT/MRI of chest, abdomen, pelvis, and rectal MRI), endoscopy, and digital rectal examination (if applicable) are recommended to undergo curative resection of colorectal cancer.

OTHER

Watch-and-wait strategy

Patients achieving clinical complete response (cCR) based on radiographic imaging (CT/MRI of chest, abdomen, pelvis, and rectal MRI), endoscopy, and digital rectal examination (if applicable) are recommended to adopt a watch-and-wait strategy.

Trial Locations (1)

510655

RECRUITING

The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER