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Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGEARLY_PHASE1

Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

Neoadjuvant Radiochemotherapy Combined With QL1706 for MSS-type Low Rectal Cancer: a Prospective, Exploratory, Multicohort Study

NCT06931873•Changhai Hospital

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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.

Key Dates

Start Date

May 20, 2025

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2035

Last Updated

April 17, 2025

Enrollment

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

SCRT+Capoex+QL706

COMBINATION_PRODUCT

LCRT+Capoex+QL706

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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