A Single-arm Clinical Trial of Pirfenidone Plus Sintilimab Combined With Standard Neoadjuvant Chemotherapy for Patients With Colorectal Cancer Peritoneal Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- ORR
研究概览
简要总结
Assuming that the objective response rate (ORR) of neoadjuvant chemotherapy in patients with colorectal cancer peritoneal metastasis is approximately 0.40 , a total sample size of 30 patients is required.
Step 1:
Ten patients will be initially enrolled. If the number of responders (CR/PR) is < 2, the study will be terminated early for futility.
If the number of responders is > 8, the treatment regimen will be considered effective, and the study may be concluded early.
Step 2:
If the number of responders in Step 1 is between 2 and 8, the study will continue to enroll an additional 20 patients until completion.
Treatment regimen: CapeOX + Pirfenidone + Sintilimab
CapeOX:
Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks
Pirfenidone:
Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen)
Sintilimab:
200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply.
Tumor response evaluation will be performed after 4 treatment cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age between 18 and 75 years;
- •Radiologically (CT/MRI/PET-CT/FAPI-PET) or pathologically confirmed peritoneal metastasis from colorectal cancer;
- •Planned to receive first-line chemotherapy;
- •ECOG performance status of 0-1;
- •Adequate hematologic, hepatic, and renal function:
- •Neutrophil count ≥ 1.5 × 10⁹/L
- •Platelet count ≥ 100 × 10⁹/L
- •Hemoglobin ≥ 8.0 g/dL
- •Creatinine clearance > 30 mL/min
- •For patients without liver metastasis: AST and ALT ≤ 2.5 × upper limit of normal (ULN)
- •Total bilirubin ≤ 2 × ULN
- •APTT and PT ≤ 1.5 × ULN
排除标准
- •Individuals with a tendency to bleed, hereditary bleeding disorders, or evidence of coagulation abnormalities;
- •Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception;
- •Expected survival ≤ 3 months;
- •Participation in another investigational drug trial within the past 4 weeks;
- •Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or immune checkpoint pathways);
- •Uncontrolled neurological or psychiatric disorders that may affect compliance or the ability to report treatment responses;
- •Known allergy to any study drug.
研究组 & 干预措施
pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy
干预措施: pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy (Drug)
结局指标
主要结局
ORR
时间窗: 3months
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a best overall response of Complete Response (CR) or Partial Response (PR) during neoadjuvant therapy, as assessed by the investigator according to RECIST v1.1 criteria.
次要结局
- Overall survival(2years)
- Safety(6months)
研究者
Guoxiang Cai
Director, Professor
Fudan University