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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044717
Enrollment
Unknown
Registered
2021-03-26
Start date
2020-01-01
Completion date
Unknown
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant serous cavity effusion

Interventions

Sponsors

Beijing University of Chinese Medicine Shenzhen Hospital (Longgang)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
Quality of life;Therapeutic effect of TCM syndromes;Objective response rate;

Secondary

MeasureTime frame
Overall Survival;progress Free Survival;ATPPase expression in serum, hydrothorax and ascites;SDHPase expressiom in serum, hydrothorax and ascites;CEA expression iin serum, hydrothorax and ascites;CA125 expression in serum, hydrothorax and ascites;VEGF expression in serum, hydrothorax and ascites;CD3+ expression in serum, hydrothorax and ascites;CD8+ expression in serum, hydrothorax and ascites;

Countries

China

Contacts

Public ContactFeng Gaofei

Beijing University of Chinese Medicine, Shenzhen Hospital

623875730@qq.com+86 17722656941

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026