💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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