RecruitingPhase 2NCT06903858

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

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


Sponsor

Sun Yat-sen University

Enrollment

105 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining an immunotherapy drug (toripalimab) with an anti-inflammatory drug (celecoxib) before surgery can shrink locally advanced colorectal cancer that has a specific genetic feature (called dMMR or MSI-H) making it more likely to respond to immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with colorectal cancer confirmed by biopsy - Your cancer is locally advanced (has grown into nearby tissue or lymph nodes) but has NOT spread to distant organs - Your tumor has the dMMR or MSI-H genetic marker - You have not received any prior cancer treatment (surgery, chemo, radiation) for this cancer - Your organs (heart, liver, kidneys) are functioning well enough for treatment **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have a complete bowel obstruction, active bleeding, or perforation needing emergency surgery - You have had prior immunotherapy (anti-PD-1/PD-L1 or anti-CTLA-4) - You have an active autoimmune disease or serious heart condition - You have untreated HIV or active hepatitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab 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.

PROCEDURENon-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.

PROCEDURECurative-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

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NCT06903858


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