Clinical trial NCT06931873: Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer
Official title: Neoadjuvant Radiochemotherapy Combined With QL1706 for MSS-type Low Rectal Cancer: a Prospective, Exploratory, Multicohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Rectal Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the efficacy of neoadjuvant radiotherapy combined with QL1706 in MSS-type low-grade rectal cancer. This study is a prospective multicohort study, with cohort 1 intended to include patients with low grade early rectal cancer (cT1-3N0M0) and cohort 2 intended to include patients with low grade locally advanced rectal cancer (cT4N0M0 or cTanyN+M0). Each cohort included 30 subjects receiving neoadjuvant radiotherapy combined with QL1706 treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients willing to receive neoadjuvant therapy.
2. Aged 18-75 years, regardless of gender.
3. Diagnosed with low-lying rectal adenocarcinoma (tumor located ≤7 cm from the anal verge) via colonoscopy, endorectal ultrasound, and pelvic high-resolution MRI, without distant metastasis.
4. Histopathologically confirmed rectal adenocarcinoma.
5. Good patient compliance, able to attend follow-up visits as required.
6. ECOG performance status score of 0-1.
7. Laboratory tests meeting the following criteria:

   i. WBC ≥3.5×10\^9/L, ANC ≥1.8×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥100 g/L.

   ii. INR ≤1.5, APTT ≤1.5×ULN, or PTT ≤1.5×ULN. iii. Total bilirubin ≤1.25×ULN; ALT/AST ≤5×ULN. iv. 24-hour creatinine clearance ≥50 mL/min or serum creatinine ≤1.5×ULN.
8. Voluntary signed informed consent.

Exclusion Criteria:

1. History of malignant colorectal tumors.
2. Patients requiring emergency surgery (e.g., intestinal obstruction, perforation, or hemorrhage).
3. Known allergy to capecitabine, oxaliplatin, PD-L1 inhibitors, CTLA-4 inhibitors, or related drugs.
4. Histopathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma.
5. Unstable systemic diseases, including but not limited to:

   Severe infection, uncontrolled diabetes, refractory hypertension, unstable angina, cerebrovascular accident, myocardial infarction, congestive heart failure, life-threatening arrhythmias, or severe hepatic/renal/metabolic disorders.
6. Conditions (e.g., psychiatric disorders, substance abuse) that may increase treatment risk, compromise compliance, or confound study results.
7. Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
8. Pregnancy, lactation, or refusal to use effective contraception during the study.
9. Other conditions deemed unsuitable by the investigator.

Primary outcomes:
measure: Complete Response Rate
timeFrame: After neoadjuvant therapy 1 month or after surgery 1 month
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years /5 years
measure: Disease Free survival
timeFrame: 3 years /5 years
measure: Wexner Fecal Incontinence Score (Wexner Score)
timeFrame: After neoadjuvant therapy 3 months or after surgery 3 months
measure: Low Anterior Resection Syndrome Score (LARS Score)
timeFrame: After neoadjuvant therapy 3 months or after surgery 3 months
measure: Short-Form 36 Health Survey (SF-36 Score )
timeFrame: After neoadjuvant therapy 3 months or after surgery 3 months
Other outcomes:
Locations:
Study officials:
References: