NCT03869892进行中（未招募）3 期
An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 856
- 试验地点
- 189
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
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
- •Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
- •RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
- •Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
- •Patient is not a candidate for curative resection of metastatic lesions.
- •No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤
- •Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'
排除标准
- •Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- •Participation in another interventional study within 4 weeks prior to the randomisation .
- •Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
- •Symptomatic central nervous system metastases.
- •Major surgery within 4 weeks prior to the randomisation.
- •Exclusion criteria related to S 95005 administration:
- •History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
- •Any contraindication present in the SmPC of trifluridine/tipiracil
- •Exclusion criteria related to bevacizumab administration:
- •Any contraindication present in the SmPC of bevacizumab
- •Exclusion criteria related to capecitabine administration:
- •Any contraindication present in the SmPC of capecitabine
研究组 & 干预措施
S95005 + Bevacizumab
Experimental
干预措施: Trifluridine/tipiracil hydrochloride (S95005) (Drug)
S95005 + Bevacizumab
Experimental
干预措施: Bevacizumab experimental (Biological)
Capecitabine + Bevacizumab
Active Comparator
干预措施: Capecitabine (Drug)
Capecitabine + Bevacizumab
Active Comparator
干预措施: Bevacizumab control (Biological)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 24 months
Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.
次要结局
- Overall Survival (OS)(Up to 8 years)
- Overall response rate (ORR)(Up to 8 years)
- Disease control rate (DCR)(Up to 8 years)
- Duration of response (DoR)(Up to 8 years)
- Time to treatment failure (TTF)(Up to 8 years)
- Incidence of Adverse Events (AEs)(Up to 8 years)
- Number of clinically significant changes to hematology, biochemistry, coagulation and urinalysis tests(Up to 8 years)
- Changes in ECOG performance status(Up to 8 years)
- Number of clinically significant changes to blood pressure, heart rate, body temperature and body weight(Up to 8 years)
- Number of clinically significant changes to 12-leads ECG parameters(Up to 8 years)
- Quality of life as assessed by EORTC QLQ-C30(Up to 8 years)
- Quality of life as assessed by EQ-5D-5L(Up to 8 years)
研究者
研究点 (189)
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