NCT06903858 Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer
| NCT ID | NCT06903858 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 105 participants in total. It began in 2025-06-01 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Signed informed consent and willingness/compliance with study procedures. 2. Age ≥18 years. 3. Histologically confirmed colorectal adenocarcinoma. 4. ECOG performance status 0-1. 5. Locally advanced primary tumor (T3/T4 and/or N+) confirmed by CT/MRI (pelvic MRI for rectal cancer). 6. dMMR (IHC) or MSI-H (PCR) status. 7. No prior anti-cancer therapy for colonrectal cancer (surgery/chemotherapy/targeted therapy/radiation). 8. Adequate organ function 9. For women of childbearing potential: negative pregnancy test and contraception use during and for 3 months post-treatment. Male participants with fertile partners must use contraception. 10. Willingness to adhere to study requirements. Exclusion Criteria: 1. Presence of distant metastases (M1) confirmed by CT/MRI or PET-CT (at least covering the chest, abdomen, and pelvis). 2. Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery. 3. Inability to achieve complete resection of the primary colorectal tumor. 4. History or concurrent active malignancy (except malignancies cured ≥5 years ago or adequately treated carcinoma in situ). 5. 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. 6. Major surgery (e.g., laparotomy, thoracotomy, organ resection via laparoscopy) or severe trauma within 4 weeks before enrollment (surgical incision must be fully healed). 7. Thromboembolic events (e.g., cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis) within 12 months before enrollment. 8. Active coronary artery disease, severe/unstable angina, or newly diagnosed angina/myocardial infarction within 12 months before enrollment. 9. New York Heart Association (NYHA) Class II or higher congestive heart failure (see Appendix 3). 10. HIV infection, AIDS, or untreated active hepatitis (HBV-DNA ≥500 IU/mL; HCV-RNA above detection limit). 11. Active inflammatory bowel disease or other colorectal disorders causing chronic diarrhea. 12. Active, known, or suspected autoimmune disease (exceptions: stable conditions like type 1 diabetes, hypothyroidism on hormone replacement, or skin disorders without systemic treatment, e.g., vitiligo, psoriasis, alopecia). 13. Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia). 14. Residual toxicity ≥Grade 2 (per CTCAE v5.0) from prior therapies (except anemia, alopecia, skin pigmentation). 15. Known or suspected hypersensitivity to any study-related drugs. 16. Pregnancy or lactation. 17. Women of childbearing potential (last menstruation \<2 years ago) or fertile men unwilling to use effective non-hormonal contraception. 18. Any unstable medical condition compromising safety or protocol compliance.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06903858 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06903858 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06903858 currently recruiting?
Yes, NCT06903858 is actively recruiting participants. Contact the research team at dengyanh@mail.sysu.edu.cn for enrollment information.
Where is the NCT06903858 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06903858 clinical trial?
NCT06903858 is sponsored by Sun Yat-sen University. The trial plans to enroll 105 participants.
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