Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06931873 | NOT YET RECRUITING | Rectal Cancer

Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer
Sponsor:

Changhai Hospital

Information provided by (Responsible Party):

Wei Zhang

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.

Condition or disease

Rectal Cancer

Intervention/treatment

SCRT+Capoex+QL706

LCRT+Capoex+QL706

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Neoadjuvant Radiochemotherapy Combined With QL1706 for MSS-type Low Rectal Cancer: a Prospective, Exploratory, Multicohort Study
Actual Study Start Date : 2025-05-20
Estimated Primary Completion Date : 2028-03-01
Estimated Study Completion Date : 2035-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

Location Details

NCT06931873

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found