ITMCTR2200005520尚未招募1 期
Fuzheng Kangai formula combined with PD-1 inhibitors for advanced non-small cell lung cancer with phlegm-dampness syndrome: a randomized, double-blind, placebo-controlled study
Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
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. According to the 8th TNM classification of lung cancer edited by International Association for the Study of Lung Cancer (IASLC) and American Joint Committee on Cancer(AJCC)patients are unable to accept surgical resection and already accepted first line treatment with histologically or cytologically confirmed metastatic or recurrent NSCLC (stage IV).
- •2. PD-L1 expression are positive and less than 50%.
- •3. The Chinese medicine syndrome diagnosed with phlegm-dampness syndrome.
- •4. Range in Age is from 18 to 80 years old.
- •5. Life expectancy is over 3 months.
- •6. The investigator confirmed the presence of at least one measurable lesion according to RECIST 1.1 criteria.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.
- •8. Hematologic function was sufficient, defined as neutrophil absolute count =1.5×109/L, platelet count =100 ×109 /L, hemoglobin =90g/L (no history of blood transfusion within 7 days)
- •9. Liver function was sufficient, defined as total bilirubin levels =1.5 times the upper normal limit (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =2.5 times ULN in all patients, or AST and ALT levels =5 times ULN in patients with liver metastasis;
- •10. Renal function was sufficient, defined as creatinine clearance = 60 mL /min (Cockcroft-Gault formula);
- •11. The function of blood clotting was sufficient, defined as international standardized ratio (INR) or prothrombin time (PT) =1.5 ULN. If the subject is receiving anticoagulant therapy, as long as PT is in the prescribed anticoagulant range, it is acceptable.
- •12. For female subjects of reproductive age, a negative urine or serum pregnancy test should be presented within 3 days prior to receiving the first study drug. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required
- •13. Sign written informed consent to participate in the study voluntarily.
排除标准
- •1. Currently participating in an interventional clinical study or receiving another study drug or study device within 4 weeks prior to initial dosing.
- •2. Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- •3. Major surgery was performed within 3 weeks prior to administration.
- •4. There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention.
- •5. A solid organ or blood system transplant has been received.
- •6. There is clinically uncontrollable pleural effusion or abdominal effusion (patients who do not need drainage effusion or who stop drainage for 3 days without significant increase in effusion can be included in the group).
- •7. The tumor compresses important surrounding organs such as the esophagus with associated symptoms.
- •8. Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia.
- •9. Severe infection should be treated with antibiotics.
- •10. Known allergic reactions to the active ingredients of pD-1 inhibitors and or to any excipients.
- •11. An active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) developed within 2 years prior to initial administration.
- •12. Patients requiring long-term systemic corticosteroid use. Patients requiring intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids for COPD or asthma may be enrolled.
- •13. Symptomatic central nervous system metastases.
研究者
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