Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

NCT ID: NCT06931873

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2035-03-01

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort1

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

Group Type: EXPERIMENTAL

SCRT+Capoex+QL706

Intervention Type: COMBINATION_PRODUCT

Using a short-course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 25 Gy (5 Gy/treatment × 5 treatments); 2 weeks of rest after the end of radiotherapy were followed by 4 cycles of Capoex combined with QL706.

Cohort2

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

Group Type: EXPERIMENTAL

LCRT+Capoex+QL706

Intervention Type: COMBINATION_PRODUCT

Using a long course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 50 Gy (2 Gy/treatment x 25 treatments); a 2-week break at the end of radiotherapy was followed by 4 cycles of Capoex combined with QL706.

Interventions

SCRT+Capoex+QL706

Using a short-course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 25 Gy (5 Gy/treatment × 5 treatments); 2 weeks of rest after the end of radiotherapy were followed by 4 cycles of Capoex combined with QL706.

Intervention Type: COMBINATION_PRODUCT

LCRT+Capoex+QL706

Using a long course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 50 Gy (2 Gy/treatment x 25 treatments); a 2-week break at the end of radiotherapy was followed by 4 cycles of Capoex combined with QL706.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhang

Director of Department of Colorectal Surgery, Changhai Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NCRQ

Identifier Type: -

Identifier Source: org_study_id