primary hepatic carcinoma
Conditions
Interventions
Control group:ACTL
Integrated Traditional Chinese and Western Medicine Treatment Group:Red Astragalus Parasitic Accumulation Formula combined with ACTL
Sponsors
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The following criteria must all be met for inclusion in the trial: (1) Diagnosis of advanced primary liver cancer: Patients with advanced or metastatic hepatocellular carcinoma (HCC) confirmed by clinical diagnostic criteria and/or pathological tissue/cytological examination meeting the Chinese Liver Cancer Staging (CNLC) stage IIIa to IIIb with Child-Pugh liver function classification of A or a better B (=7 points); (2) TCM syndrome differentiation as qi and yin deficiency damp-heat and blood stasis with toxin syndrome; (3) Age 18 to 80 years old (including 18 and 80 years old) gender unrestricted; (4) Voluntary participation in this clinical trial informed consent and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: As long as any one of the exclusion criteria is met it cannot enter the test: (1) Previously confirmed fibrolamellar hepatocellular carcinoma sarcomatoid hepatocellular carcinoma hepatobiliary duct cell carcinoma mixed liver cancer etc. by histology or cytology; (2) Have a history of hepatic encephalopathy or liver transplantation; (3) Portal vein tumor thrombus involving the main trunk and its left and right branches or simultaneously involving the main trunk and the superior mesenteric vein or with inferior vena cava tumor thrombus or cardiac involvement; (4) Those diagnosed with other malignant tumors within 5 years prior to the first administration of the drug excluding radical cutaneous basal cell carcinoma cutaneous squamous cell carcinoma and/or radical resected carcinoma in situ; (5) Within 4 weeks before the first administration moderate or severe ascites or pleural effusion ascites or pericardial effusion with clinical symptoms requiring drainage; (6) Within two weeks before the first administration the patient has received traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin interferon interleukin except for local use to control pleural effusion or ascites etc.); (7) Patients with acute or chronic active hepatitis B or C; (8) Any life-threatening bleeding events that occurred within 3 months prior to screening including those requiring blood transfusion therapy surgery or local treatment or continuous drug therapy; Have a severe bleeding tendency a history of gastrointestinal bleeding or coagulation dysfunction or are currently receiving thrombolytic therapy; (9) Those who are unable to complete the baseline assessment; (10) Combined with autoimmune diseases hematological diseases or long-term use of hormones or immunosuppressants; (11) Those with severe primary diseases of the heart lungs liver kidneys blood or serious diseases that affect their survival; (12) Pregnant women lactating women those with mental illness and those with intellectual or language disabilities; (13) Combined with a history of other organ transplants (including autologous bone marrow transplantation and peripheral stem cell transplantation); (14) Those without legal capacity for conduct or those whose research is affected by medical or ethical reasons; (15) Those who are known or suspected of being allergic to the components of the intervention drug; (16) Patients who have participated in or are currently participating in clinical trials of other drugs within the past three months; (17) Those whom the researcher deems unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;AFP\CEA\CA199\CA125\CA153;OS;Child-Pugh score for liver function;Time To Progression;Brief Fatigue Inventory;The main symptom scores of a single item in traditional Chinese medicine: including pain in the liver area fullness and distension in the epigastrium and abdomen emaciation and general weakness;EORTCQLQ-C30;Lesion control indicators;OSR;TCM Syndrome scoring;The percentage of patients with Stable Disease (SD) =4 weeks (specifically confirmed SD) among the evaluable efficacy patients; | — |
Countries
China
Contacts
Public ContactLi junxiang
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed