Applicability of Patient Derived Orthotopic Xenograft (PDOX) 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
- 90
- 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 PDOX results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
详细描述
Data of Patients who received PDOX 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
- •Undergone radical surgical resection.
- •Patients voluntarily cooperated with the study and signed an informed consent form.
- •Histopathologically diagnosed hepatocellular carcinoma.
- •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-
- •No serious heart, lung, or renal dysfunction
排除标准
- •Unable to provide specimens for PDOX testing.
- •Patients with recurrent liver cancer.
- •Developing two or more types of tumors simultaneously.
- •Patients with existing extrahepatic distant metastases.
- •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.
- •Died within 1 month 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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 with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 months after surgery.
干预措施: Doxorubicin (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))