ITMCTR2000003632尚未招募1 期
A randomized, controlled, double-blind study of fuzhengjiedu granules in combination with icotinib in the first-line treatment of EGFR-sensitive mutated advanced lung adenocarcinoma
onghua Hospital, Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •(1) Those who meet the diagnostic criteria for primary bronchopulmonary carcinoma, histologically or cytologically confirmed as adenocarcinoma, with EGFR 21 exon L858R and EGFR 19 exon deletion mutations identified by Arm method or second generation sequencing.
- •(2) Patients with non-surgical carriers of stage IIIB-IV NSCLC according to international staging criteria, or patients with carriers who have undergone surgery but have not undergone radical resection, or patients with recurrent postoperative metastases with objectively assessable tumor foci.
- •(3) Aged between 18 and 80 years at the time of diagnosis of primary bronchopulmonary cancer.
- •(4) After 1 month of taking icotinib, for patients whose TCM diagnosis belongs to Qi deficiency or Qi and Yin deficiency, the clinical diagnosis shall be confirmed by two or more attending physicians respectively.
- •(5) Have not received any prior systemic treatment.
- •(6) Survival is expected to be >= 6 months.
- •(7) Physical condition score ECOG PS <= 2.
- •(8) Routine blood neutrophil absolute value >= 1.5x10^9/L, platelet>=80x10^9/L, no obvious abnormalities in liver and kidney function.
- •(9) Willingness to accept the pilot programme and sign the informed consent.
排除标准
- •(1) Lack of objective evaluation of the tumour foci.
- •(2) Those with an acute infection that has not been controlled, or with septic and chronic infections that have persistent wounds.
- •(3) Persons who have used antipyretic or adrenocorticosteroid medications within 1 week, or who have taken oral pain medications containing NSAIDs for long-term pain control.
- •(4) Refusal to accept this trial protocol.
- •(5) Patients with symptomatic brain metastases.
研究者
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