Combination of Toripalimab and Celecoxib for Advanced Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Toripalimab, an immune checkpoint inhibitor, combined with Celecoxib for patients with locally advanced colorectal cancer that is deficient in mismatch repair (dMMR) or has high microsatellite instability (MSI-H). The approach aims to evaluate the effectiveness and tolerability of this neoadjuvant treatment, potentially allowing patients to avoid surgical resection. The study focuses on patients who have not received prior anti-cancer therapies and have a confirmed diagnosis of colorectal adenocarcinoma. The trial will assess clinical and pathological responses to determine if non-surgical treatment can be a viable option for these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yanhong Deng, MD.
• Email: dengyanh@mail.sysu.edu.cn
• Phone: 020-38379762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.