ITMCTR1900002748
Not yet recruiting
Phase 1
A multicenter randomized controlled trial to assess the efficacy of cancer green therapy in treatment of stage IIIb/IV non-small cell lung cancer
Dongfang Hospital Beijing University of Chinese Medicine0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients with histologically or cytologically confirmed NSCLC, and clinical stage IIIb or IV.
- •(2\) One of above five TCM syndrome pattern differentiation;
- •(3\) There is at least one lesion larger than 2cm in diameter that can be cryoablation in the lung;
- •(4\) The Eastern Cooperative Oncology Group (ECOG) score \<\= 2 and the expected survival time was more than 3 months
- •(5\) Aged more than 18 years;
- •(6\) Able to read Chinese and willingness to provide signed informed consent.
Exclusion Criteria
- •(1\) Patients who had received any radiation, chemotherapy, targeted therapy or immunotherapy for their cancers within a month;
- •(2\) Patients with symptomatic brain metastases;
- •(3\) Patients with infectious and radioactive inflammation around the lesion, or skin infection and ulceration at the puncture site;
- •(4\) Patients with severe pulmonary fibrosis especially drug\-induced pulmonary fibrosis;
- •(5\) Patients with severe bleeding tendency, platelet less than 50×109/L and severe coagulation disorders;
- •(6\) Patients with poor control of ipsilateral malignant pleural effusion;
- •(7\) Pregnant and lactating women; or severe insufficiency of liver, kidney, heart, lung and brain; or severe anemia, dehydration and serious disorders of nutrition metabolism, unable to be corrected or improved in a short time; or patients with severe systemic infection and high fever (T \> 38\.5 degree C).
- •(8\) HIV antibody positive or with other acquired or congenital immunodeficiency diseases;
- •(9\) Patients with a history of organ transplantation;
- •(10\) Patients enrolled in other clinical trials within three months.
Outcomes
Primary Outcomes
Not specified
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