Liver cancer
Conditions
Interventions
treatment group:Trial group: First-level expert recommendation (Class 1A evidence) for Shuangda and Shuangai patients with liver function Child-Pugh score =7 who had not previously received systematic
control group:Control group: Selected patients were treated with Shuangda/Shuangai, and the dosage was the same as that of experimental group.
Sponsors
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years old, gender is not limited; (2) Histologically, cytologically confirmed HCC or clinically diagnosed HCC meeting the criteria of the American Association for the Study of Liver Diseases; (3) Measurable disease according to RECIST version 1.1 response assessment criteria; (4) unresectable, locally advanced or metastatic HCC at diagnosis, eligible for Barcelona clinical HCC(BCLC) stage C or not suitable for radical surgery or local treatment of stage B; (5) The patient's physical activity status (PS) score was 0-1 (Schedule 1), Child-Pugh liver function score was 7 or below (Schedule 2), and life expectancy was more than 12 weeks; (6) The TCM syndrome type of the treatment group was consistent with the syndrome of positive deficiency and stasis.
Exclusion criteria
Exclusion criteria: (1) History of autoimmune disease and liver transplantation; (2) acute or chronic active HBV or hepatitis C virus (HCV) infection, HBVDNA greater than 2000 IU /mL or 1054 copies per ml-HCVRNA greater than 10³ copies /mL, hepatitis B surface antigen and anti-HCV antibody positive at the same time (allowing nucleotide antiviral therapy); (3) Central nervous system metastasis, main portal vein and left and right branches were all involved by portal vein tumor thrombus, or the main artery and superior mesenteric vein existed simultaneously, and inferior vena cava tumor thrombus existed; (4) Endoscopic assessment of known severe varicose veins, or evidence of high risk of portal hypertension bleeding; (5) interstitial lung disease, pulmonary fibrosis; (6) Other systemic tumor therapy and local regional therapy for target lesions are not allowed, but local palliative radiotherapy and bone metastasis therapy for isolated lesions (non-liver lesions) are allowed to control symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Half-year PFS rate;HCC symptom grading quantified score;EORTC QLQ-HCC18 Score; | — |
Countries
China
Contacts
Public ContactZhang Hongliang
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Outcome results
None listed