A Phase II, Randomized, Double-blind, Multi-center, Placebo-Controlled Study of the Efficacy and Safety of CEND-1 in Combination With Chemotherapy as First-Line Therapy in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~80 years old, male or female;
- •Locally advanced unresectable or metastatic PDAC confirmed by histopathology or cytopathology;
- •Patients who have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer;
- •Patients with at least one measurable tumor lesion per RECIST v1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Expected survival time ≥ 12 weeks;
- •Patients who have adequate organ function;
- •Female subjects who are not pregnant or not breastfeeding. A negative pregnancy test for females of childbearing potential within 7 days prior to first dosing. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.
- •Subjects participate voluntarily and sign informed consent.
排除标准
- •Concurrent use of other anticancer drugs, including chemotherapy, targeted therapy, immunotherapy, or biologics;
- •The patients who are known to be allergic to the investigatinal drug or its any excipient;
- •Patients with the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention within 6 months before signing the ICF;
- •Patients with high risk for gastrointestinal bleeding or abdominal bleeding as assessed by the investigator, such as tumor invasion of the gastro duodenum finger intestines, large blood vessels, etc.;
- •Patients with symptomatic CNS metastasis, leptomeningeal metastasis, or spinal cord compression due to metastasis.
- •Patients with other active malignant tumors within 3 years before signing the ICF. Patients with cured skin basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroid cancer can be enrolled.
- •Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis or co-infection with hepatitis B and C.
- •Patients who require systemic antibiotics for ≥7 days within 4 weeks prior to first dose, or unexplained fever >38.5°C prior during screening or before first dose;
- •Patients who participated in any other clinical studies;
- •Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse; History of definitive neurological or mental disorder, including epilepsy or dementia;
- •The patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
研究组 & 干预措施
CEND-1+ nab-paclitaxel + gemcitabine
Participants will receive nab-paclitaxel 125mg/m2; CEND1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: CEND-1 (Drug)
CEND-1+ nab-paclitaxel + gemcitabine
Participants will receive nab-paclitaxel 125mg/m2; CEND1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Gemcitabine (Drug)
CEND-1+ nab-paclitaxel + gemcitabine
Participants will receive nab-paclitaxel 125mg/m2; CEND1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Nab paclitaxel (Drug)
Placebo+ nab-paclitaxel + gemcitabine
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Gemcitabine (Drug)
Placebo+ nab-paclitaxel + gemcitabine
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Nab paclitaxel (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Approximately 36 months
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
次要结局
- Overall Survival (OS)(Approximately 36 months)
- Progression Free Survival(PFS)(Approximately 36 months)
- 6-month PFS rate(Approximately 36 months)
- Duration Of Response (DOR)(Approximately 36 months)
- Disease Control Rate (DCR)(Approximately 36 months)
- Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs)(From the subject signs the ICF to 30 days after the last dose of study drug was administered.)