NCT03926338View on ClinicalTrials.gov

Toripalimab With or Without Celecoxib as Neoadjuvant Therapy in Resectable dMMR/MSI-H Colorectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

May 10, 2019

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2030

Conditions
Colorectal CancerMismatch Repair-deficient (dMMR)Microsatellite Instability-high (MSI-H)Neoadjuvant Therapy
Interventions
DRUG

Cohort 1: Neoadjuvant treatment with toripalimab plus celecoxib for 3 months

Toripalimab (IV given over 30 min at a dose of 3mg/m2 on day 1, every 2 weeks for 3 months) and Celecoxib (oral 200mg twice daily for 3 months) followed by surgical resection.

DRUG

Cohort 1: Neoadjuvant treatment with toripalimab monotherapy for 3 months

Toripalimab (IV given over 30 min at a dose of 3mg/m2 on day 1, every 2 weeks for 3 months) followed by surgical resection.

DRUG

Cohort 2: Neoadjuvant treatment with toripalimab plus celecoxib for 6 months

Toripalimab (IV given over 30 min at a dose of 3mg/m2 on day 1, every 2 weeks for 6 months) and Celecoxib (oral 200mg twice daily for 6 months) followed by surgical resection.

DRUG

Cohort 2: Neoadjuvant treatment with toripalimab monotherapy for 6 months

Toripalimab (IV given over 30 min at a dose of 3mg/m2 on day 1, every 2 weeks for 6 months) followed by surgical resection.

Trial Locations (1)

510655

RECRUITING

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

All Listed Sponsors
lead

Sun Yat-sen University

OTHER