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RECRUITING
NCT06903858
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The PICC-3 study is a multicentre, single-arm, phase II trial evaluating toripalimab plus celecoxib in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced colorectal cancer. The trial uses a response-adapted treatment strategy, whereby patients with clinical complete response (cCR) after therapy may enter a non-operative management pathway, while patients without cCR proceed to surgery. Response assessment is based on imaging, endoscopy, biopsy evaluation, and ctDNA analysis.

Official title: Toripalimab Plus Celecoxib With Response-adapted Non-operative Management for Mismatch Repair-deficient or Microsatellite Instability-high Locally Advanced Colorectal Cancer (PICC-3): a Multicenter, Single-arm, Phase 2 Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-06-01

Completion Date

2031-04-01

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

Toripalimab plus celecoxib

Toripalimab is administered intravenously at 3 mg/kg over 30 minutes once every 2 weeks for a total of 12 doses. Celecoxib is administered orally at 200 mg twice daily for 6 months.

PROCEDURE

Non-operative management

Patients achieving clinical complete response (cCR) according to comprehensive response assessment, including imaging, endoscopy, digital rectal examination (if applicable), and ctDNA evaluation, may undergo non-operative management.

PROCEDURE

Curative-intent surgery

Patients who do not achieve cCR will undergo curative-intent surgery.

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China