An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 57
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
- •Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- •RAS status must have been determined (mutant or wild).
- •Has at least one measurable metastatic lesion.
- •No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- •Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
- •Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
- •Is able to take medication orally (i.e., no feeding tube).
- •Has adequate organ function.
- •Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
- •Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.
排除标准
- •Is a pregnant or lactating female.
- •Has certain serious illness or serious medical condition(s) as described in the protocol.
- •Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
- •Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
- •Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •Has contra-indication to bevacizumab or capecitabine.
研究组 & 干预措施
Trifluridine/tipiracil + bevacizumab
Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.
Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.
Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.
干预措施: Trifluridine/tipiracil + bevacizumab (Drug)
Capecitabine + bevacizumab
Capecitabine was administered at 1250 mg/m² orally BID (bis in die)on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks
干预措施: Capecitabine + bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.
次要结局
- Overall Response Rate (ORR)(Baseline and every 8 weeks (maximum follow-up duration: 17.9 months))
- Duration of Response (DR)(Baseline and every 8 weeks (maximum follow-up duration: 16.6 months))
- Disease Control Rate (DCR)(Baseline and every 8 weeks (maximum follow-up duration: 17.9 months))
- Overall Survival (OS)(Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months))