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RECRUITING

NCT07898865

PHASE2

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

Sponsor: Chongqing University Cancer Hospital

View on ClinicalTrials.gov

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.

Official title: Neoadjuvant Chemotherapy Plus Serplulimab Before Versus After Short-Course Radiotherapy in Locally Advanced Rectal Cancer : A Multicenter, Randomized Phase II Study With Integrated Multi-omics Profiling (NeoCSR-Omics Trial)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-10-16

Completion Date

2028-10-01

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Rectal Cancer Patients Locally Advanced Rectal Cancer (LARC)

Interventions

RADIATION

radiotherapy

1. Short-course pelvic radiotherapy 2. IMRT/VMAT/TOMO, 25 Gy in 5 fractions (5 Gy per fraction)

DRUG

CAPOX (oxaliplatin/capecitabine)

* Capecitabine: 1000 mg/m² orally BID, D1-14, every 3 weeks * Oxaliplatin: 130 mg/m² IV, D1, every 3 weeks

DRUG

Serplulimab

Serplulimab (HLX10): 300 mg IV, D1, every 3 weeks

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.

Locations (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China