NCT07448077招募中2 期
Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- complete response Rate (pCR+cCR )
研究概览
简要总结
Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.age >=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .
- •4.Staged as T3-4 NanyM0 or T1-2N+ M0 according to the AJCC 8th edition. 5.Rectal cancer: <10 cm from the anal verge. 6.Adequate organ function:
- •Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. ii. Platelet count ≥ 100 × 10⁹/L . iii. Hemoglobin ≥ 90 g/L.
- •Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Creatinine ≤ 1.5 × ULN ; Renal: Calculated Creatinine Clearance (CrCl) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)
- •Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
- •7. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment.
- •8. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments.
排除标准
- •Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma.
- •Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer.
- •Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment.
- •Has active infection, including but not limited to HIV, or positive HBV/HCV viral load requiring antiviral therapy for control and stabilization.
- •Significant cardiovascular disease, such as myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, or hypertension that remains uncontrolled above 160/100 mmHg despite optimal therapy.
- •History of other malignant tumors, excluding non-melanoma skin cancer and cervical carcinoma in situ that have been curatively treated and disease-free for ≥ 5 years.
- •Uncontrolled diabetes (HbA1c > 8%) or thyroid dysfunction requiring medication for abnormal TSH.
- •Severe chronic intestinal conditions，including but not limited to Crohn's disease or active ulcerative colitis.
- •The investigators believe that patients were inappropriate for participation.
研究组 & 干预措施
short-course radiotherapy and immunotherapy
Experimental
patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart
干预措施: Experimental: short-course radiotherapy and immunotherapy (Drug)
chemoradiotherapy
Active Comparator
Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy
干预措施: Chemoradiotherapy (Drug)
结局指标
主要结局
complete response Rate (pCR+cCR )
时间窗: up to 2 year
Clinical complete response or pathological complete response (cCR or pCR)
次要结局
- Major pathologic response rate(up to 2 year)
- R0 resection rate(The R0 resection rate will be evaluated after surgery, an average of 4 weeks)
- 3-year event-free survival (EFS) rate(up to 3 years)
- 3-year overall survival (OS)(up to 3 years)
- Adverse Event(up to 2 year)
研究者
Fengpeng WU, MD
Hebei Medical University Fourth Hospital
Hebei Medical University Fourth Hospital
研究点 (1)
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