Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт SCRT+Capoex+QL706
  Using a short-course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 25 Gy (5 Gy/treatment × 5 treatments); 2 weeks of rest after the end of radiotherapy were followed by 4 cycles of Capoex combined with QL706.
• Комбинированный продукт LCRT+Capoex+QL706
  Using a long course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 50 Gy (2 Gy/treatment x 25 treatments); a 2-week break at the end of radiotherapy was followed by 4 cycles of Capoex combined with QL706.

Первичные конечные точки

• Complete Response Rate [Срок оценки: After neoadjuvant therapy 1 month or after surgery 1 month]

Вторичные конечные точки (5)

• Overall survival [Срок оценки: 3 years /5 years]
• Disease Free survival [Срок оценки: 3 years /5 years]
• Wexner Fecal Incontinence Score (Wexner Score) [Срок оценки: After neoadjuvant therapy 3 months or after surgery 3 months]
• Low Anterior Resection Syndrome Score (LARS Score) [Срок оценки: After neoadjuvant therapy 3 months or after surgery 3 months]
• Short-Form 36 Health Survey (SF-36 Score ) [Срок оценки: After neoadjuvant therapy 3 months or after surgery 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06931873 · NCRQ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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