Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Exploring the precise medicine of patients with primary hepatobiliary cancer. And evaluate the efficacy and safety of individualized treatment regimens for primary hepatobiliary cancer based on next-generation sequencing.
详细描述
The purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug efficacy, progression free and overall survival. This trial study is based on genetic tests, then therapeutic target drugs are administered according to the genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit from precise treatment which targets particular genetic abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary cancer patients.
The genetic tests are performed for the eligible subjects in this study, then therapeutic target drugs are administered according to the genetic test reports. While the precise treatments, follow-ups are conducted to evaluate the efficacy and safety of the target drugs for the subjects, until the overall survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age from 18 to 65, male or female.
- •Radiologically and pathologically confirmed as hepatobiliary cancers with stage IV.
- •Palliative care as the preferred.
- •The result of next-generation sequencing (NGS) test show the patient has gene mutation and also can be treated by the right commercial products that have been approved by the China Food and Drug Administration (CFDA) or the Food and Drug Administration (FDA).
- •ECOG performance status 0-
- •Life expectancy ≥3 months.
- •Agree to sign informed consent form.
排除标准
- •Hepatobiliary cancer patient with stageI-III, or with any of the following items will not be eligible for screening. Such as, suitable for the treatment of radical resection, radical resection but evaluation unmeasurable.
- •The result of NGS test show the patient has no gene mutation, or has gene mutation but no medicine.
- •ECOG performance status ≥
- •Female patients who are pregnant or not using a contraceptive method of birth control.
- •History or presence of serious cardiovascular or cerebrovascular abnormalities.
- •Abnormalities of the hepatic or renal functions, such as jaundice, ascites, bilirubin ≥ 1.5×ULN, alkaline phosphatase ≥ 3×ULN, persistent protein urine≥ grade 3 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0), creatinine ratio > 3.5g/24 hours, renal failure.
- •Persistent infection > grade 2 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0).
- •Patient has underwent a major operation 4 weeks prior to screening or has not yet recovered from the operation.
- •Patient with epilepsy, known or untreated brain metastases.
- •The presence of wounds, ulcers or fractures that can not be healed, or with a past history of transplantation.
- •The presence of bleeding events ≥grade 3 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0) , present evidence or past history of coagulation dysfunction disorders.
- •Known human immunodeficiency virus (HIV) infection history.
- •Patient with drug abuse or unstable compliance.
- •The presence of unresolved toxicity caused by any previous treatment/operation > grade 1 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0), except alopecia, anemia or hypothyroidism).
- •Investigator consider that the patient should not be enrolled in this study by careful assessment.
- •The subjects participate in any other clinical trial in the meantime.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year
Time of progression will be obtained by telephone interview or medical treatment records.
次要结局
- Objective response rates (ORR)(From treatment initiation to CR or PR, up to 2 years)
- Duration of Response (DOR)(From treatment initiation to PD, up to 2 years)
- Adverse Drug Reaction (ADR)/Adverse Event (AE)(Through study completion, an average of 2 years.)
- Disease Control Rate (DCR)(From treatment initiation to SD, CR or PR, up to 2 years)
- Quality of Life (QoL) after treatment(Through study completion, an average of 2 years.)
- Overall Survival (OS)(2 years)