A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- anti-tumor activity
研究概览
简要总结
This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer).
There are 2 portions in this study.
- Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection.
- Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.
详细描述
The target population is composed by patients who have confirmed adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable, with tumor distal margin within 10 cm of the anal verge, with no evidence of distant metastatic disease, ECOG performance 0-1, and adequate bone marrow, renal and hepatic function.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Prior history of pelvic radiation therapy
- •Hypersensitivity to fluoropyrimidine
- •Uncontrolled serious medical or psychiatric illness
- •Myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months
- •No more than 4 weeks since prior participation in any investigational drug study
- •Major surgery within 28 days
- •Other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
- •Cardiovascular disease that would preclude study treatment or follow-up
- •Informed consent not duly signed and dated to participate in the study
研究组 & 干预措施
PEP503+5-FU/capecitabine+Radiotherapy
Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
干预措施: PEP503 (Drug)
PEP503+5-FU/capecitabine+Radiotherapy
Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
干预措施: 5-fluorouracil (Drug)
PEP503+5-FU/capecitabine+Radiotherapy
Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
干预措施: capecitabine (Drug)
PEP503+5-FU/capecitabine+Radiotherapy
Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
干预措施: surgical resection (Procedure)
PEP503+5-FU/capecitabine+Radiotherapy
Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
anti-tumor activity
时间窗: up to 36 months
Anti-tumor activity as assessed by response rate (RR, as per RECIST 1.1) of PEP503 at the recommended volume given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
safety profile /the Dose Limiting Toxicity (DLT)
时间窗: up to 36 months
Safety as assess the safety profile and determine the Dose Limiting Toxicity (DLT) of PEP503 given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
the recommended volume (dose)
时间窗: up to 36 months
recommended volume (dose) of PEP503 examined by given as intratumor injection and activated by external beam radiation. with concurrent chemotherapy in patients with unresectable rectal cancer
次要结局
未报告次要终点