Green Therapy of Cancer 002 (GTC002): National Key R&D Program of China: A Multicenter, Randomized Controlled Trial of Green Therapy for Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- stage IIIB-IV non-small cell lung cancer
- Registration Number
- ITMCTR1900002370
- Lead Sponsor
- Dongfang Hospital, Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Histologic or cytologic diagnosis of NSCLC and the 8th TNM system of lung cancer staging IIIb-IV based on IASLC;
(2) One of five syndromes including deficiency of both qi and yin,qi deficiency of spleen and lung, deficiency of lung yin, stagnation of qi and blood stasis and phlegm-heat obstructing lung based on the TCM diagnosis and treatment of lung cancer (2017) issued by State Administration of Traditional Chinese Medicine of the People's Republic of China;
(3) At least one lesion of diameter >2cm exsiting in the lung that was capable of cryoablation;
(4) Eastern Cooperative Oncology Group (ECOG) performance status less than 2 points and life expectancy of at least 3 months;
(5) Aged >=18 years;
(6) Patients volunteer to participate, and sign the informed consent.
(1) Cancer treatment including radiotherapy, chemotherapy, targeted therapy or immunotherapy within one month;
(2) Symptomatic brain metastasis;
(3) Poor control of infectious and radioactive inflammation around the target lesion or skin infection and ulceration at the puncture site;
(4) Severe pulmonary fibrosis especially induced by drug;
(5) Severe bleeding tendency, platelet less than 50×109/L and severe coagulation disorder;
(6) Poor control of malignant pleural effusion in the ipsilateral of cryoablation;
(7) Pregnancy or lactation, or severe dysfuction of liver, kidney, heart, lung and brain, or severe anemia, dehydration and metabolism disorders which cannot be corrected or improved in short-term , or severe systemic infection with high fever (T>38.5 degree C);
(8) Antibody of HIV is positive, or other acquired/congenital immunity;
(9) Organ transplantation;
(10) Participating in other clinical trials within recent three months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method survival time;
- Secondary Outcome Measures
Name Time Method progression-free survival;quality of life;Objective Response Rate;