Long-course chemoradiation or short-course radiation with CAPOX, PD-1 antibody, and celecoxib for MSS locally advanced rectal 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 is a randomized phase II trial enrolling 138 patients with T3-4/N+ M0 rectal adenocarcinoma located within 10 cm of the anal verge and confirmed MSS/pMMR. Participants are assigned 1:1 to long-course chemoradiotherapy (LCRT) followed by three cycles of CAPOX, or short-course radiotherapy (SCRT) followed by four cycles of CAPOX combined with a PD‑1 antibody; all patients receive oral celecoxib during chemotherapy. Total mesorectal excision (TME) is planned after total neoadjuvant therapy, while patients achieving a clinical complete response may be offered a watch-and-wait approach. The primary endpoint is complete response rate (pathologic plus clinical complete responses), with secondary endpoints including grade 3–4 acute adverse event rate, anal preservation rate, and 3-year disease-free survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years, gender not limited
2. Pathologically confirmed rectal adenocarcinoma
3. ≤10 cm from the anus
4. Baseline stage T3-4/N+
5. No distant metastasis
6. MSI/MMR status MSS/pMMR
7. Karnofsky performance status score ≥70
8. No prior chemotherapy or other anti-cancer treatment prior to enrollment
9. No prior immunotherapy prior to enrollment
10. Ability to comply with the study protocol
11. Written informed consent

Exclusion Criteria:

1. Pregnancy or breast-feeding women;
2. Known history of other malignancies within 5 years;
3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;
4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
7. Uncontrolled infection which needs systemic therapy;
8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
10. Allergic to any component of the therapy.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Zhen Zhang, M.D, PH.D — Fudan University
• Study coordinator: Zhen Zhang, M.D, PH.D
• Email: zhen_zhang@fudan.edu.cn
• Phone: 18801735029

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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.