Liver cancer
Conditions
Interventions
Control group :First-line targeted drugs
Treatment group:First-line targeted drugs combined with Gankang granules
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age from 18 to 75 years old, male and female; ? Patients with locally advanced or metastatic hepatocellular carcinoma diagnosed with definite pathological diagnosis cannot be treated with liver surgery and/or other local treatment (ablation or hepatic artery intervention), or recurrence and progression after surgery and/or other local treatment; ? No prior first-line systemic therapy for advanced or metastatic hepatocellular carcinoma; ?At least one measurable target lesion (the longest single diameter =10mm non-lymph node lesion, or the short diameter =15mm lymph node lesion); For the lesions after previous local treatment such as ablation, radiotherapy or hepatic artery interventional therapy, CT/MRI examination must be performed and disease progression must be confirmed according to mRECIST standards, with the longest diameter =1.0cm, which can also be used as measurable target lesions. ? After liver surgery > 3 months, ablation or hepatic artery interventional therapy > 4 weeks, and related adverse reactions returned to normal; If patients who have gone beyond the norm of systemic adjuvant chemotherapy or targeted therapy after surgery or other local therapy need > 6 months to end chemotherapy or targeted therapy and develop disease progression and/or metastasis; ?Child-Pugh liver function score is A or better B (=7 points); ?ECOG physical status score was 0-1; ?The expected survival time was =12 weeks; ? Within 2 weeks before the first administration of this study, no modern Chinese medicine preparations with liver cancer indication were used: Kanglet injection/soft capsule, Aidi or Kangsaidi injection, elemene injection/oral liquid, Huaier granule, Bufalin and Ganforle capsule/tablet, etc. ? The functions of major organs are basically normal, meeting the following requirements: Bone marrow: Neutrophil absolute count =1.5×109/L, platelet =80×109/L, hemoglobin =90g/L; Liver: total bilirubin =1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase =5 times the upper limit of normal value, albumin =30g/L; Kidney: serum creatinine =1.5 upper limit of normal value, or creatinine clearance rate =50mL/min;
Exclusion criteria
Exclusion criteria: ? If the ascites with moderate or higher volume is clinically significant, that is, therapeutic peritoneal puncture/drainage is required, or child-Pugh score of this index is > 2; ? Hepatobiliary duct cell carcinoma and fibrolamellar cell carcinoma; Patients with previous or co-existing cancers with primary foci or histology completely different from hepatocellular carcinoma, but who have been cured of malignancy 5+ years ago, are eligible for inclusion; ? Pregnant or lactating women; ? Patients with hypertension who cannot be well controlled by antihypertensive drugs (systolic blood pressure > 140mmHg, diastolic blood pressure > 100mmHg); ? The occurrence of hepatic encephalopathy and/or hepatic nephropathy within 6 months; ? Other conditions considered by the investigator to prevent patients from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms of gankang granule advantage population;Disease control rate(DCR);Quality of life(QoL);Changes in urinary metabolites;Objective Response Rate(ORR);Overall Survival(OS);Frequency of common adverse reactions to targeted drugs;Evaluation of TCM symptoms;Characteristics of TCM syndrome;Changes in intestinal flora structure and abundance; | — |
Countries
China
Contacts
Public Contactzhenghonggang
Outcome results
None listed