A Prospective Cohort Study on the Treatment of Malignant Hydrothorax and Ascites with Recombinant Human Endostatin Based on Cold and Heat Syndrome Differentiation of Traditional Chinese Medicine
- Conditions
- Malignant serous cavity effusion
- Registration Number
- ITMCTR2100004633
- Lead Sponsor
- Beijing University of Chinese Medicine Shenzhen Hospital (Longgang)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
(1) The diagnosis of malignant hydrothorax and ascites was confirmed by histopathology or cytological examination of hydrothorax and ascites. (2) There was no antineoplastic treatment within one month before treatment and no contraindications for the use of pleural and abdominal biological response regulators. (3) The estimated survival time is more than 3 months, and the KPS score is more than 60. (4) With the age of 18-75 years old, regardless of sex. (5) Informed consent was signed and volunteer for treatment.
(1) Those who complicated with cardiovascular, kidney, hematopoietic system and other serious primary diseases or psychosis.
(2) Pregnant or lactating women, those who are allergic constitution and allergic to drugs.
(3) Those who cannot use drugs in accordance with the regulations, so that it's unable to judge the efficacy of treatment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life;Therapeutic effect of TCM syndromes;Objective response rate;
- Secondary Outcome Measures
Name Time Method CA125 expression in serum, hydrothorax and ascites;CEA expression iin serum, hydrothorax and ascites;progress Free Survival;VEGF expression in serum, hydrothorax and ascites;SDHPase expressiom in serum, hydrothorax and ascites;ATPPase expression in serum, hydrothorax and ascites;CD3+ expression in serum, hydrothorax and ascites;CD8+ expression in serum, hydrothorax and ascites;Overall Survival;