NeoCSR-Omics: CAPOX and Serplulimab Before or After Short-Course RT in 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 multicenter, randomized phase II study evaluating neoadjuvant CAPOX chemotherapy plus serplulimab in patients with locally advanced rectal cancer. Participants are assigned to receive serplulimab either before or after a short course of radiotherapy, with the aim of maximizing complete response rates. The primary endpoint is the rate of complete response (pathological plus clinical). Secondary endpoints include safety, perioperative outcomes, survival, recurrence patterns, and integrated multi-omics analyses of paired tumor samples to identify predictive biomarkers. The study will also explore how sequencing of chemotherapy, radiotherapy, and immunotherapy may influence the tumor immune environment and treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-70 years, any sex.
* Clinical stage II/III rectal adenocarcinoma (cT3-T4N0 or cT2-T4N+, M0) according to AJCC 8th edition.
* Tumor located ≤10 cm from anal verge (confirmed by colonoscopy or digital rectal exam).
* Histologically confirmed rectal adenocarcinoma.
* ECOG performance status 0-1.
* Adequate organ function:
* Hemoglobin ≥90 g/L; WBC ≥3.5×10⁹/L; ANC ≥1.5×10⁹/L; Platelets ≥100×10⁹/L.
* Serum creatinine, BUN ≤1.0×ULN.
* ALT, AST, ALP ≤1.5×ULN; Total bilirubin ≤1.5×ULN.
* Negative urine protein; normal coagulation.
* No known allergy to fluoropyrimidines or platinum.
* No prior surgery (except diverting colostomy), chemotherapy, or radiotherapy for primary rectal cancer.
* No prior pelvic radiotherapy.
* Signed written informed consent.

Exclusion Criteria:

* Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors, or other investigational immunotherapies.
* Active autoimmune disease (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis, scleroderma, SLE, vasculitis).
* Symptomatic interstitial lung disease or active pneumonia.
* GI conditions increasing risk of perforation (e.g., active diverticulitis, abscess, obstruction).
* History of other malignancies, except cured non-melanoma skin cancer or in situ cervical cancer.
* Active infections, uncontrolled heart failure, recent myocardial infarction (\<6 months), unstable angina, or severe arrhythmia.
* Other uncontrolled disease or condition that may interfere with study participation.
* Pregnancy or lactation.
* Known immunodeficiency (e.g., HIV) or history of organ/allo-HSCT transplantation.
* Active HBV (HBV DNA ≥2000 IU/mL), HCV infection, or active tuberculosis.
* Receipt of cancer vaccines or live vaccines within 4 weeks prior to enrollment (seasonal inactivated influenza vaccines allowed).
* Concurrent use of other investigational agents, long-term corticosteroids, or immunosuppressants.
* Psychiatric disorders, substance abuse, or social conditions limiting compliance.
* Known allergy or contraindication to study drugs.

Where it's running

• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Qishuai Guo
• Email: cqzlyygqs@163.com
• Phone: +86-1399602842

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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.