Status:
NOT_YET_RECRUITING
Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer
Lead Sponsor:
Changhai Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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 incl...
Eligibility Criteria
Inclusion
- Patients willing to receive neoadjuvant therapy.
- Aged 18-75 years, regardless of gender.
- 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.
- Histopathologically confirmed rectal adenocarcinoma.
- Good patient compliance, able to attend follow-up visits as required.
- ECOG performance status score of 0-1.
- 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.
- Voluntary signed informed consent.
Exclusion
- History of malignant colorectal tumors.
- Patients requiring emergency surgery (e.g., intestinal obstruction, perforation, or hemorrhage).
- Known allergy to capecitabine, oxaliplatin, PD-L1 inhibitors, CTLA-4 inhibitors, or related drugs.
- Histopathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma.
- 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.
- Conditions (e.g., psychiatric disorders, substance abuse) that may increase treatment risk, compromise compliance, or confound study results.
- Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
- Pregnancy, lactation, or refusal to use effective contraception during the study.
- Other conditions deemed unsuitable by the investigator.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2035
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06931873
Start Date
May 20 2025
End Date
March 1 2035
Last Update
April 17 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.