💬In plain words
What the trial is, and whether it could suit you
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 (25
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📋 Eligibility rules (as published)
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.
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