Neoadjuvant chemoradiotherapy with QL1706 for MSS low-rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, exploratory phase 2/3 trial evaluating neoadjuvant chemoradiotherapy combined with QL1706, a dual PD-1/CTLA-4 antibody, in adults with MSS-type low-rectal cancer. Patients are stratified into two cohorts by tumor stage and receive either short-course or long-course radiotherapy plus chemotherapy and immunotherapy before surgery. The study will measure complete response rates (clinical and pathological) and track 3- and 5-year overall and disease-free survival, along with safety and tolerability. Eligible participants are adults aged 18-75 with MSS, tumor within 7 cm of the anal margin, no distant metastases, and adequate organ function. Primary institutions include Shanghai Changhai Hospital in Shanghai, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.