Neoadjuvant Radiochemotherapy Combined With QL1706 for MSS-type Low Rectal Cancer: a Prospective, Exploratory, Multicohort Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Complete Response Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort1
Patients with low rectal cancer, clinical stage cT1-3N0M0
干预措施: SCRT+Capoex+QL706 (Combination Product)
Cohort2
Patients with low locally advanced rectal cancer with clinical stage cT4N0M0 or cTanyN+M0
干预措施: LCRT+Capoex+QL706 (Combination Product)
结局指标
主要结局
Complete Response Rate
时间窗: After neoadjuvant therapy 1 month or after surgery 1 month
Includes clinical complete response rate (cCR) and pathologic complete response rate (pCR)
次要结局
- Overall survival(3 years /5 years)
- Disease Free survival(3 years /5 years)
- Wexner Fecal Incontinence Score (Wexner Score)(After neoadjuvant therapy 3 months or after surgery 3 months)
- Low Anterior Resection Syndrome Score (LARS Score)(After neoadjuvant therapy 3 months or after surgery 3 months)
- Short-Form 36 Health Survey (SF-36 Score )(After neoadjuvant therapy 3 months or after surgery 3 months)
研究者
Wei Zhang
Director of Department of Colorectal Surgery, Changhai Hospital
Changhai Hospital