Study of Chinese Medicine Plus Targeted Therapy Maintenance Versus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma: A Randomized Double-blind Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3 years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of targeted maintenance therapy.
详细描述
Maintenance therapy refers to systemic therapy that may be given for patients with advanced NSCLC after 4 to 6 cycles of first-line chemotherapy. However, patients are only candidates for maintenance therapy if they have responded to their previous treatment or have stable disease and their tumors have not progressed. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKIs) such as Iressa and Erlotinib have proved effective in first or second line therapy for advanced pulmonary adenocarcinoma. Targeted therapy maintenance can be partly extend patient's TTP, but the toxicity and the side effects of targeted therapy will decrease QOL. Besides, high cost of targeted therapy will cause greater economic pressure on patients.The investigators' preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival time and improve QOL, but high-level evidences are needed.
The investigators perform a multicenter, randomized, double blind controlled, prospective study in advanced pulmonary adenocarcinoma patients with stage Ⅲ～Ⅳ. Advanced pulmonary adenocarcinoma patients after first-line chemotherapy will choose maintenance therapy according to the patient's wishes, including targeted therapy maintenance, chemotherapy maintenance and TCM maintenance therapy. Patients who choose targeted therapy maintenance are randomized over observational group (TCM granules plus targeted therapy maintenance),and control group (TCM placebo plus targeted therapy maintenance). The treatment should be continued until evidence of disease progression or unacceptable toxicity, and after that regular follow-up will be arranged. The primary efficacy assessments are: OS (overall survival); Secondary efficacy assessments are: (1) PFS (progression-free survival); (2) Objective response rate; (3) QOL (Functional Assessment of Cancer therapy-lung, FACT-L4.0 scales; Lung Cancer Symptom Scale, LCSS); (4) other efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with targeted therapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of targeted therapy maintenance. Therefore the study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Pathologically or cytologically confirmed of stage IIIa-IV pulmonary adenocarcinoma;
- •The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
- •Age ≥18 years old;
- •Physical status score (ECOG PS) ≤ 2 scores;
- •Estimated life expectancy of at least 12 weeks;
- •Participants have no major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;
- •Planning for targeted maintenance.
- •Informed consent from the patient.
排除标准
- •The efficacy evaluation of the first-line therapy is progressive disease(PD);
- •Patient with other malignant tumor except NSCLC 5 years previous to study entry;
- •Patient has already received chemotherapy or other anticancer treatment;
- •Estimated life expectancy less than 12 weeks;
- •Brain metastasis (controlled brain metastasis and steroid free need is excluded);
- •History of cardiovascular disease: Congestive Heart Failure > grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;
- •Pregnant or child breast feeding women;
- •Mental or cognitive disorders;
研究组 & 干预措施
TCM granules plus EGFR-TKIs
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity.
干预措施: YiQiFang (Drug)
TCM granules plus EGFR-TKIs
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity.
干预措施: YangYinFang (Drug)
TCM granules plus EGFR-TKIs
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity.
干预措施: YiQiYangYinFang (Drug)
TCM granules plus EGFR-TKIs
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity.
干预措施: Erlotinib® (Drug)
TCM granules plus EGFR-TKIs
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity.
干预措施: Gefitinib® (Drug)
TCM granules plus EGFR-TKIs
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity.
干预措施: Icotinib® (Drug)
Placebo granules plus EGFR-TKIs
Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity.
干预措施: placebo granules (Drug)
Placebo granules plus EGFR-TKIs
Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity.
干预措施: Erlotinib® (Drug)
Placebo granules plus EGFR-TKIs
Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity.
干预措施: Gefitinib® (Drug)
Placebo granules plus EGFR-TKIs
Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity.
干预措施: Icotinib® (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 2 months
It referred to the interval time from the first date of randomization to that of death for any reason, the end of the study, or loss of follow-up.
次要结局
- Quality of life (QOL)(2 months)
- Progression-free survival (PFS)(2 months)
- Objective response rate (ORR)(2 months)
研究者
Ling Xu
Principal Investigator
Shanghai University of Traditional Chinese Medicine