Multicenter randomized controlled clinical trial for therapeutic Evaluation of TCM in patients with extensive small cell lung cancer (SCLC)
- Conditions
- extensive small cell lung cancer
- Registration Number
- ITMCTR1900002318
- Lead Sponsor
- Beijing Hospital of TCM, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) patients diagnosed with small cell lung cancer by cytology or histology with distant organ metastasis and/or lymph node metastasis of the contralateral hilar lung in extensive stage (via cranial MRI, chest CT, bone scan, abdominal CT or PET/CT);
(2) did not receive radiotherapy, chemotherapy or surgical treatment, with evaluable lesions;
(3) ECOG score 2, and the expected survival time is > for 3 months;
(4) aged 18-75 years, with serious diseases of heart, brain, kidney, liver, blood and other systems;
(5) agree to participate in this study and sign the informed consent.
(1) massive pleural or peritoneal effusion or pericardial effusion causes dyspnea;
(2) symptomatic bone metastases requiring radiotherapy;
(3) brain metastasis;
(4) pregnant or lactating women, or serious diseases of heart, lung, liver, kidney, blood and other systems;
(5) patients who are known to be allergic to the study drugs;
(6) patients undergoing other drug trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety index;OS;
- Secondary Outcome Measures
Name Time Method TCM syndromes related to lung cancer;PFS;tumor markers;ORR;QOL;