NCT06931873Not yet recruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 Apr 2025
- Start date
- 20 May 2025
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Changhai Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06931873
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 20 May 2025 to the primary completion date, 1 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
Other illness
- 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.
- 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.
- Other conditions deemed unsuitable by the investigator.
Other
- Histopathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma.
- Pregnancy, lactation, or refusal to use effective contraception during the study.
Who the study is looking for
- 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:
- WBC ≥3.5×10\^9/L, ANC ≥1.8×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥100 g/L.
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.