Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of Taiwan Cooperative Oncology Group
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- 134 patients for each of the two treatment arms are needed.
研究概览
简要总结
* OBJECTIVES
- To investigate whether adjuvant IFN-α therapy can delay or reduce the 2-5 years recurrence rate in curatively resected HCC .
- To examine whether adjuvant IFN-α therapy can prolong the disease-free survival in curatively resected HCC.
- To determine the safety and tolerance of adjuvant IFN-α therapy in postoperative HCC with or without cirrhosis.
- To investigate the change of activity of HBV and HCV in postoperative HCC patients with adjuvant IFN-α therapy.
- To correlate the changes of viral status with the clinical outcome in post-operative HCC patients with adjuvant IFN-α therapy.
详细描述
- TREATMENT PLAN
1.1 Eligible patients are randomized to receive adjuvant IFN-α for 53 wks or 1.2 Administration of IFN-α 1.21 IFN-α will be started after randomization. 1.22 IFN-α will be administered by subcutaneous injection at the bed time. 1.23 Escalation of IFN-α dosage. 1.231 During the first 2 days, 1 x 106 u/day will be given. 1.232 If tolerable, the dose of IFN-α will be escalated to 3 x 106 u/day in days 3 and 4, and to 5 x 106 u/day at day 5.
1.24 After dose escalation, IFN-α 5 x 106 u/day will be given in the following ways 1.241 induction therapy: 5 times per week for the first 4 weeks, followed by 1.242 maintenance therapy: 3 times per weeks for additional 48 weeks. 1.25 Modification of IFN-α dosage 1.251 In the presence of any moderate adverse events (as listing in Appendix II) it required a dose reduction to 3 x 106 u/day.
1.2511 If any moderate adverse events occur at the 3 x 106 u/day level, the patients will be withdraw from the study; 1.252 In the presence of any severe adverse events (as listing in Appendix II), it requires immediate discontinuation of therapy; 1.2521 IFN-α will be discontinued until a return to baseline or moderate toxicity. Then IFN-α will be reinstituted at the dose level of 3 x 106 u/day; 1.2522 If moderate or severe adverse events occur at the 3 x 106 u/day level, the patients will be withdraw from the study.
1.253 Flare-up of hepatitis activity, as manifested by increment of serum transaminase per se is not an indication for dose modification; 1.254 If symptoms/signs (S/S) of hepatic decompensation occur after the presence of ALT flare-up during IFN-α therapy, the drug will be held.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Histologically proven hepatocellular carcinoma.
- •HCC underwent curative resection within 6 weeks before registration.
- •Grossly, the resection margin should be > 1 cm.
- •Patients must be younger than 70 year-old.
- •Patients must have a performance status of ECOG score <
- •Patients must have adequate liver reservation and adequate hemogram.
- •Pugh-Child's Score <
- •The serum total bilirubin level are < 2 mg/dl.
- •The prothrombin times are < 3 sec above normal control.
- •The platelet are > 10 x 104 / mm
- •The WBC are > 3,000 / mm
- •Patient must have serum creatinine < 1.5 mg/dl
- •Cardiac function with NYHA classification < Grade II
- •Known HBV or HCV status.
- •Signed informed consent.
排除标准
- •Patients who have non-curative resection are not eligible.
- •Resected HCCs with histologically positive margins are not eligible.
- •HCCs with radiological evidence of portal vein thrombus are not eligible.
- •Patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
- •Patients with advanced second primary malignancy are not eligible.
- •Patients with pregnacy or breast-feeding are not eligible.
- •Patients with severe cardiopulmonary diseases are not eligible.
- •Patients with clinically significant psychiatric disorder are not eligible.
- •Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
结局指标
主要结局
134 patients for each of the two treatment arms are needed.
次要结局
未报告次要终点