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Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer
Sponsor: Sun Yat-sen University
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
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.
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.
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