Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens.
详细描述
This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens. The mutations involved include the following: A: FGFR, B: IDH1, C: KRAS, D: NTRK, E: BRAF V600E, F: BRCA1/2, G: HER2, and H: pan-negative. Additional corresponding targets may be added later based on clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •The patient voluntarily joins this study and signs the informed consent form.
- •Age: ≥18 years, male or female.
- •Histologically or cytologically confirmed advanced biliary tract malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
- •No prior systemic therapy for advanced BTC (biliary tract cancer).
- •At least one measurable lesion as per RECIST v1.1 (spiral CT scan long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm; lesions previously treated with local therapy may be considered target lesions only after documented progression according to RECIST v1.1).
- •ECOG performance status: 0-
- •Expected survival ≥12 weeks.
- •Adequate major organ function.
- •Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before the first dose, must not be breastfeeding, and must voluntarily agree to use effective contraceptive measures during the study period and for 6 months after the last dose of chemotherapy. For male subjects with a female partner of childbearing potential, they must be surgically sterile or agree to use effective contraceptive measures during the study period and for 3 months after the last dose of chemotherapy; sperm donation is not allowed during the study.
- •Subjects are expected to have good compliance and be able to follow the protocol requirements for efficacy and adverse event follow-up.
排除标准
- •Has another active malignancy other than BTC within 5 years or concurrently.
- •Has poorly controlled cardiac clinical symptoms or diseases.
- •Has hypertension that cannot be reduced to normal range with antihypertensive medication; has a history of hypertensive crisis or hypertensive encephalopathy.
- •Any clinically significant gastrointestinal disorders, including bleeding, inflammation, obstruction, or diarrhea > grade
- •Has experienced thrombotic or embolic events within 6 months before the start of study treatment.
- •Use of strong CYP3A4/CYP2C19 inducers (including rifampin and its analogues, and St. John's Wort) or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent form.
- •Has uncontrolled infection at screening.
- •Patients with congenital or acquired immunodeficiency.
- •Has a history of brain metastases or has brain metastases.
- •Women who are pregnant or plan to become pregnant during the study treatment period.
- •Other patients deemed unsuitable for inclusion by the treating physician.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From enrollment to upto 2 years
Objective Response Rate (ORR), defined as the proportion of subjects in the analysis population who have a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1.
次要结局
- Progression-Free Survival (PFS)(From enrollment to upto 2 years)
- Overall Survival (OS)(From enrollment to upto 3 years)
- Disease Control Rate (DCR)(From enrollment to upto 2 years)
研究者
TingBo Liang
The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang University