NCT06903858
Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer
Recruiting · Phase 2 · Sun Yat-sen University · registry updated 2026-05-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Signed informed consent and willingness/compliance with study procedures.
- Age ≥18 years.
- Histologically confirmed colorectal adenocarcinoma.
- ECOG performance status 0-1.
- Locally advanced primary tumor (T3/T4 and/or N+) confirmed by CT/MRI (pelvic MRI for rectal cancer).
- dMMR (IHC) or MSI-H (PCR) status.
Exclusion
- Presence of distant metastases (M1) confirmed by CT/MRI or PET-CT (at least covering the chest, abdomen, and pelvis).
- Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- Inability to achieve complete resection of the primary colorectal tumor.
- History or concurrent active malignancy (except malignancies cured ≥5 years ago or adequately treated carcinoma in situ).
- Prior treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways.
- Major surgery (e.g., laparotomy, thoracotomy, organ resection via laparoscopy) or severe trauma within 4 weeks before enrollment (surgical incision must be fully healed).