jRCT2031240225招募中不适用
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naive HER2-expressing BTC. (DESTINY-BTC01)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 620
- 主要终点
- Safety and tolerability
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 99age old under（—）
- 性别
- All
入选标准
- •Participants must be 18 years of age or more at the time of screening. Other age restrictions may apply as per local regulations;
- •Male and female;
- •Unresectable, previously untreated, locally advanced or metastatic BTC. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 6 months (180 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
- •histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC;
- •Provision of FFPE tumor sample that is no older than 3 years;
- •At least one target lesion assessed by the Investigator based on RECIST v1.1 (randomized portion only);
- •WHO/ECOG performance status of 0 or 1;
- •Adequate organ and bone marrow function within 14 days before randomization;
- •Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential;
排除标准
- •Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines;
- •histologically confirmed ampullary carcinoma;
- •history of substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions;
- •spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
- •medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke;
- •Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment;
- •active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening;
- •Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG;
- •History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening;
- •Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder;
- •Prior pneumonectomy (complete);
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals;
- •Active primary immunodeficiency, known uncontrolled active HIV infection or HCV;
- •Pregnant or breastfeeding female patients, or patients who are planning to become pregnant;
- •Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 6 months prior to randomization, or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study (only randomized portion).
结局指标
主要结局
Safety and tolerability
Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.
Overall survival (OS) in FAS (HER2 IHC 3+) population
OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS.
次要结局
未报告次要终点
研究者
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