Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

Naval Military Medical University

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Rectal Cancer

Treatments: Combination Product: SCRT+Capoex+QL706; Combination Product: LCRT+Capoex+QL706

Study type: Interventional

Funder types: Other

Identifiers

NCT06931873

NCRQ

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cohort1

Experimental group

Description:

Patients with low rectal cancer, clinical stage cT1-3N0M0

Treatment:

Combination Product: SCRT+Capoex+QL706

Cohort2

Experimental group

Description:

Patients with low locally advanced rectal cancer with clinical stage cT4N0M0 or cTanyN+M0

Treatment:

Combination Product: LCRT+Capoex+QL706