CTRI/2024/02/063127进行中（未招募）3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary. Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 8
- 主要终点
- Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ]
研究概览
简要总结
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator’s choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria: 1 Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1) 2 Provision of a tumor sample collected at surgical resection.
- •3 Randomization within 12 weeks after resection with adequate healing and removal of drains.
- •4 Confirmed to be disease-free by imaging within 28 days prior to randomization.
- •5 Eastern Cooperative Oncology Group performance status of 0 or 1.
排除标准
- •Exclusion Criteria: 1 Participants with locally advanced, unresectable, or metastatic disease at initial diagnosis.
- •3 Any anti-cancer therapy for BTC prior to surgery 4 Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease 5 Current or prior use of immunosuppressive medication within 14 days before the first dose 6 Thromboembolic event within 3 months 7 Active HBV or HCV infection unless treated.
结局指标
主要结局
Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ]
时间窗: Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ]
次要结局
- Overall Survival (OS) for Arm A vs. Arm B [ Time Frame: up to 7 years ](Overall survival is defined as the time from randomization until the date of death due to any cause.)
- Patient-reported tolerability Arm A vs. Arm B [ Time Frame: Up to approximately 7 years. ](Patient-reported tolerability is a multi-component endpoint defined as the proportion of participants in each arm reporting side effect bother, clinically meaningful impact on physical functioning and descriptive data on treatment-related symptoms.)
- Progression Free Survival (PFS) following recurrence Arm A vs. Arm B. [ Time Frame: Up to approximately 7 years. ](Progression-free survival following recurrence is defined as the time from randomization until the earliest progression event after the start of the first subsequent therapy or death.)
研究者
Mr Sandeep AV
AstraZeneca Pharma India Ltd
研究点 (8)
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