NCT02854072Unknown3 期
A Prospective, Randomized, Open-label, Multicenter, Parallel Design, Phase III Study to Assess the Efficacy and Safety of GV1001 Concurrent With Gemcitabine/Capecitabine Versus Gemcitabine/Capecitabine Alone in Treating Locally Advanced and Metastatic Pancreatic Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 148
- 试验地点
- 16
- 主要终点
- Overall Survival
研究概览
简要总结
To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.
详细描述
This study is designed as a phase III, prospective, randomized, open-label, multicenter clinical trial comparing GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in treating locally advanced and metastatic pancreatic cancer patients. Patients will be treated until disease progression and will be subject to follow-up until death.
Patients will be randomized equally between the two arms:
- Gemcitabine and Capecitabine
- GV1001+ Gemcitabine and Capecitabine
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas.
- •Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer.
- •Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up to a maximum of 32 days) prior to commencing treatment.
- •Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines.
- •ECOG performance status 0, 1 or
- •Adequate organ function as determined by the following laboratory values:
- •Platelets ≥100 x 10^9 /L
- •WBC ≥ 3 x 10^9 /L
- •ANC ≥1.5 x 10^9 /L
- •Serum total bilirubin ≤ 2.0 mg/dL
- •CCr (Cockcroft & Gault) > 50 mL/min
- •Life expectancy ≥ 90 days
- •Fully informed written consent given.
排除标准
- •Brain metastasis or meningeal carcinomatosis.
- •Clinically significant serious disease or organ system disease not currently controlled on present therapy.
- •Previous chemotherapy for locally advanced and metastatic disease. Previously adjuvant chemotherapy for resected pancreatic cancer will be permitted providing chemotherapy was completed more than 12 months previously.
- •Radiotherapy within the last 8 weeks prior to start of study treatment.
- •Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer.
- •Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms.
- •Administration of medicines from other clinical trials within 8 weeks from registration.
- •Pregnancy or breast feeding.
- •Uncontrolled angina pectoris.
- •Known malabsorption syndromes.
- •Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency.
- •All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
- •Investigator's judgment against participation in the study
研究组 & 干预措施
GV1001 + gemcitabine/capecitabine
Experimental
干预措施: GV1001 (Drug)
GV1001 + gemcitabine/capecitabine
Experimental
干预措施: Gemcitabine (Drug)
GV1001 + gemcitabine/capecitabine
Experimental
干预措施: Capecitabine (Drug)
gemcitabine/capecitabine
Active Comparator
干预措施: Gemcitabine (Drug)
gemcitabine/capecitabine
Active Comparator
干预措施: Capecitabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: one year
次要结局
- Time to tumor progression (TTP)(one year)
- Objective response rate (ORR)(one year)
- Clinical benefit response (CBR)(one year)
- Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL)(one year)
- Quality of Life using EORTC QLQ-C30(up to one year)
- Quality of Life using EQ-5D-3L(up to one year)
- Change in CA19-9 (Serum cancer antigen) over time(one year)
- Toxicity according to the NCI CTCAE v4.03(one year)
研究者
研究点 (16)
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