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RECRUITING

NCT07866313

PHASE2/PHASE3

Neoadjuvant Chemoradiotherapy Combined With QL1706 for MSS-Type Low-Rectal Cancer

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

Summary

he goal of this prospective, exploratory clinical trial is to learn if neoadjuvant chemoradiotherapy combined with QL1706 (a dual PD-1/CTLA-4 antibody) can effectively treat in patients with MSS-type low rectal cancer (tumor lower edge ≤ 7cm from the anal verge, aged 18-75). The main questions it aims to answer are: What is the complete response (CR) rate, including clinical complete response (cCR) and pathological complete response (pCR)? What are the 3-year and 5-year overall survival (OS) and disease-free survival (DFS) rates? Researchers will compare two cohorts of patients based on tumor stage (Cohort 1: early low rectal cancer cT1-3N0M0; Cohort 2: locally advanced low rectal cancer cT4N0M0 or cTanyN+M0) to see if the combination treatment yields different efficacy and safety outcomes depending on the disease stage. Participants will: Receive either short-course radiotherapy (25Gy/5 fractions) or long-course radiotherapy (50Gy/25 fractions) based on their assigned cohort. Receive 4 cycles of chemotherapy (Capeox: Capecitabine + Oxaliplatin) combined with QL1706. Undergo assessments including pelvic MRI, endorectal ultrasound, and digital rectal exams to evaluate tumor regression. Based on the tumor response, undergo surgery (radical resection or local excision) or enter a Watch \& Wait follow-up protocol. Provide blood, urine, stool, and tissue samples for biomarker and exploratory analyses.

Official title: A Prospective, Exploratory Study on the Efficacy of Neoadjuvant Chemoradiotherapy Combined With QL1706 in Patients With MSS-type Low-stage Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-01

Completion Date

2031-12-01

Last Updated

2026-10-08

Healthy Volunteers

Conditions

MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706

Interventions

DRUG

Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab

Short-course chemoradiotherapy was administered, with a total tumor dose of 25 Gy to the primary tumor and high-risk areas (5 Gy per session, 5 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were given (every 3 weeks): On Day 1, QL706 was administered at 5 mg/kg via intravenous infusion; oxaliplatin was given at 130 mg/m² via intravenous infusion. From Day 1 to Day 14, capecitabine was taken orally at 850-1000 mg/m², twice daily.

DRUG

Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab

Long-term radiotherapy was administered to the primary tumor and high-risk areas, with a total dose of 50 Gy (2 Gy per session, 25 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were administered (every 3 weeks): On Day 1, QL706 was given at a dose of 5 mg/kg via intravenous infusion; oxaliplatin was administered at a dose of 130 mg/m² via intravenous infusion from Day 1 to Day 14. Capecitabine was taken orally at a dose of 850-1000 mg/m², twice daily, from Day 1 to Day 14.

Inclusion Criteria: * Willing to receive neoadjuvant therapy. * Age 18-75 years; any gender. * Histopathologically confirmed rectal adenocarcinoma. * Low rectal cancer confirmed by colonoscopy, endoscopic ultrasound, and high-resolution pelvic MRI, with the tumor lower edge ≤7 cm from the anal margin and no distant metastases. * Microsatellite stable (MSS) status determined by PCR-capillary electrophoresis, with all 5 loci stable. * ECOG performance status 0-1. * Adequate laboratory values: * White blood cell count ≥3.5×10\^9/L, absolute neutrophil count ≥1.8×10\^9/L, platelet count ≥100×10\^9/L, and hemoglobin ≥100 g/L. * INR ≤1.5 and APTT ≤1.5× upper limit of normal (ULN), or partial prothrombin time (PTT) ≤1.5× ULN. * Total bilirubin ≤1.25× ULN; ALT and AST ≤5× ULN. * 24-hour creatinine clearance ≥50 mL/min or serum creatinine ≤1.5× ULN. * Voluntary signed informed consent. Exclusion Criteria: * History of malignant colorectal tumors. * Intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery. * Known allergy to capecitabine, oxaliplatin, PD-L1 antibodies, CTLA-4 antibodies, or similar drugs. * Pathology indicating poorly differentiated adenocarcinoma or signet-ring cell carcinoma. * Any unstable systemic disease, including but not limited to severe infection, uncontrolled diabetes, medication-uncontrolled hypertension, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious arrhythmia requiring medical treatment, or hepatic, renal, or metabolic disease that may be life-threatening. * Comorbidities or conditions (e.g., mental illness, alcoholism, or drug abuse) that may increase the risk of poor response to the investigational drug, affect compliance with trial requirements, or confound study results. * Receipt of any other investigational drug or participation in another interventional clinical trial within 30 days before screening. * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; men or women unwilling to use effective contraception. * Any other circumstance in which the investigator determines the patient is unsuitable for the clinical trial.

Locations (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China