A multicenter randomized controlled trial to assess the efficacy of cancer green therapy in treatment of stage IIIb/IV non-small cell lung cancer

Phase 1

• Conditions: lung cancer

• Registration Number: ITMCTR1900002748
• Lead Sponsor: Dongfang Hospital Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival time;