Applicability of 3D Histoculture Drug Response Assay(3D-HDRA) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The one-year DFS rate
研究概览
简要总结
This Randomized Controlled Trial was to clarity the clinical feasibility of 3D-HDRA results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
详细描述
Data of Patients who received 3D-HDRA after primary liver cancer radical reaction and received Transarterial Chemoembolization #will be collected #excluding incomplete data.
The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily cooperated with the study and signed an informed consent form.
- •Any gender, age 18 or older, 75 or younger.
- •Patients who need to confirm the maximum tumor load (the maximum diameter of a single tumor lesion) before performing radical surgery; patients with a confirmed diagnosis of primary liver cancer after postoperative pathological histological examination.
- •Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).
- •Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
- •ECOG physical fitness status score of 0-
- •Women of childbearing age with a negative pregnancy test and willing to use effective contraception for the duration of the study.
排除标准
- •Patients with recurrent liver cancer.
- •Patients with existing extrahepatic distant metastases (including local lymph node metastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time of diagnosis.
- •Treatment with other experimental drugs or other interventions after radical resection.
- •Patients with other malignant tumors that have not been cured within 5 years.
- •Patients with non-radical resections (R1 and R2 resections).
- •Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery.
- •Patients in whom death occurred within 30 days after surgery.
研究组 & 干预措施
the test group
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Oxaliplatin (Drug)
the test group
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Doxorubicin (Drug)
the test group
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Lobaplatin (Drug)
the test group
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Cisplatin (Drug)
the test group
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Oxaliplatin, Leucovorin, fluorouracil (Drug)
the test group
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Lobaplatin, Raltitrexed (Drug)
the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Oxaliplatin (Drug)
the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Doxorubicin (Drug)
the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Lobaplatin (Drug)
the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Cisplatin (Drug)
the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Oxaliplatin, Leucovorin, fluorouracil (Drug)
the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
干预措施: Lobaplatin, Raltitrexed (Drug)
结局指标
主要结局
The one-year DFS rate
时间窗: From the start date of the Treatment until date of the time of 1 year
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year
次要结局
- Adverse events(From the beginning of therapy until the date of death from any cause(max 24 months))