A Prospective, Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of donafenib combined with S-1 in treating Patients with metastatic pancreatic cancer after chemotherapy with Nab-paclitaxel plus gemcitabine regimen.
详细描述
While NG ( Nab-paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after NG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received donafenib and S-1. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.
The efficacy and safety data will be assessed through OS, ORR, DCR, PFS,TTP and adverse effects as graded by NCI CTC-AE 5.0.
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
- •Informed consent and willing to complete the study according to the protocol.
- •Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender
- •ECOG performance scale 0-1;
- •Diagnosed as pancreatic adenocarcinoma by histology and cytology;
- •Treatment of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen(The disease progresses during the course of treatment or within 6 months after the end of treatment, with clear imaging evidence; this does not include patients with intolerable toxicity)；
- •Baseline blood routine and biochemical indexes meet the following criteria:
- •Blood routine examination criteria must be met: (no blood transfusion within 14 days)
- •ANC≥1.5×109/L；
- •PLT≥100×109/L.
- •Biochemical tests are subject to the following criteria:
- •BIL <1.25xULN ；
- •ALT and AST<2.5ULN；
- •Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance>60ml/min ( Cockcroft-Gault formula).
- •Albumin≥28g/L.
- •Blood coagulation indexes are subject to the following criteria:
- •Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;
- •Activated partial thromboplastin time（APTT）≤1.5 × ULN.
- •According to the standard of RECIST 1.1, there is at least one imaging measurable lesion;
- •Life expectancy ≥ 3 months;
- •Patients and their families were willing to cooperate with follow-up.
排除标准
- •Diagnosis of malignant diseases other than pancreatic cancer within 5 years prior to first administration (excluding cured skin basal cell carcinoma, squamous carcinoma of the skin, and/or resected carcinoma in situ);
- •Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
- •Patients with brain metastases or pial metastases;
- •Patients with a clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- •Comorbidities (e.g., severe or uncontrolled hypertension, severe diabetes, and/or thyroid disease) that, in the investigator's judgment, seriously endanger patients' safety or prevent them from completing the study;
- •The patient was currently participating in an interventional clinical study or had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
- •The patient had a history of organ transplantation;
- •Concurrent administration of drugs that may prolong QTc and/or induce Tdp;
- •Patients also take drugs that affect drug metabolism;
- •HIV infection or acute or chronic viral hepatitis (hbSAG positive, HBV-DNA load ≥500IU/ml and/or HCV antibody positive);
- •Excluded patients with serious cardiovascular disease, including grade ≥II cardiac dysfunction (NYHA criteria);
- •Patients with severe gastrointestinal dysfunction (bleeding, infection, obstruction, or diarrhea greater than grade 1) were excluded;
- •Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy were excluded;
- •Patients with a severe arterial thromboembolism event within 6 months were excluded;
- •Excluding women who are pregnant or breast-feeding.
研究组 & 干预措施
Experimental: Donafenib + S-1
Donafenib: 200mg po bid； S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.
干预措施: Donafenib (Drug)
Experimental: Donafenib + S-1
Donafenib: 200mg po bid； S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.
干预措施: S1 (Drug)
结局指标
主要结局
Overall Survival
时间窗: through study completion, an average of 1 year
To evaluate the overall survival of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.
次要结局
- Progression Free Survival(through study completion, an average of 1 year)
- Overall Response Rate(through study completion, an average of 1 year)
- Incidence of Adverse Events(through study completion, an average of 1 year)