NCT07898865 NeoCSR-Omics Trial: CAPOX + Serplulimab Before vs. After Short-course RT in LARC

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 100 participants in total. It began in 2025-10-16 with a primary completion date of 2027-10-01.

Brief Summary

This is a prospective, randomized, multicenter phase II trial evaluating neoadjuvant CAPOX chemotherapy combined with the PD-1 inhibitor serplulimab administered either before or after short-course radiotherapy (SCRT) in patients with locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, defined as pathological complete response (pCR) plus clinical complete response (cCR). Secondary endpoints include safety, perioperative outcomes, survival, recurrence patterns, and integrated multi-omics analyses of paired tumor samples. The study aims to determine the optimal sequencing strategy and identify immune microenvironmental biomarkers predictive of response.

Eligibility Criteria

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.

Contact & Investigator

Frequently Asked Questions

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.