Liver cancer
Conditions
Interventions
Treatment group:Pien Tze Huang Capsules
Control group:Antike Capsules
Sponsors
The First Affiliated Hospital of Guangzhou University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Patients who are confirmed primary liver cancer in accordance with the clinical diagnostic criteria from the "Guidelines for primary liver cancer diagnosis and treatment" (2011 edition), or by pathological histology or cytology examination, and at least has one measurable lesions (RECIST 1.1); 3. Patients who are unable or refuse to accept surgery, local therapy (hepatic artery embolization chemotherapy, hepatic arterial infusion chemotherapy, radiofrequency ablation, cryoablation or percutaneous ethanol injection), radiation therapy, chemotherapy, or molecular targeted therapy; 4. Patients who have primary liver cancer with Child - Pugh liver function grade rating A - B, BCLC stage at B - C stage; 5. In accordance with TCM syndrome differentiation standard of liver blood stasis type; 6. Expected lifetime =12 weeks; 7. One week before recruitment ECOG PS score is 0 to 2; 8. Major organs functions are normal, which meet the following criteria: (1) Blood routine: HGB=85g/LANC=1.5×10^9/LPLT=60×10^9/L (2) Kidney function: Creatinine =1.5×ULN; 9. In the last four weeks received no surgery, radiotherapy, chemotherapy, local treatment (hepatic artery embolization chemotherapy, hepatic arterial infusion chemotherapy, radiofrequency ablation, cryoablation or percutaneous ethanol injection), targeted therapy, biological therapy or other systemic anti-tumor treatment; 10. Women of childbearing age should carry out pregnancy test (serum or urine) 7 days before recruitment with negative results, and are willing to use adequate contraceptives once signe the informed consent; men of childbearing age should agree to use adequate contraceptives once sign the informed consent; 11. Participants should be willing to join in this study, sign informed consent, have good compliance, and cooperate during the follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients who are taking part in other clinical studies or were accepting other research theropy within 30 days before the screening visit; 2. 4 weeks before participate in the study patients who had the following treatment: surgery, radiotherapy, chemotherapy, local treatment (hepatic artery embolization chemotherapy, hepatic arterial infusion chemotherapy, radiofrequency ablation, cryoablation or percutaneous ethanol injection), targeted therapy or biological treatment; 3. Patients who have confirmed hepatic duct carcinoma, mixed cell carcinoma and fiberboard layer cell carcinoma; in the past (within 5 years) or now had or have other non-cured malignant tumor, except cured skin basal cell carcinoma and cervical carcinoma; 4. Patients who have a variety of factors which affect oral drugs (such as unable to swallow, chronic diarrhea and intestinal obstruction, which can significantly affect the drug taking and absorption); 5. Patients who have severe myocardial ischemia or myocardial infarction, severe arrhythmia, Level III - IV cardiac insufficiency; 6. Patients who had or have objective evidences on pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, severe damaged pulmonary function and etc; 7. Patients who had a history of bleeding or haemoptysis within 3 months; Or who have severe complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding or obstruction; 8. Within 28 days before the study patients who had abdominal fistula, gastrointestinal perforation or abdominal abscess; 9. Patients who have suffered central nervous system metastases or known brain metastases; 10. Patients who have a mental illness, or a history of psychiatric drug abuse; 11. Women during pregnancy or lactation; Patients with fertility who are unwilling or unable to take effective contraceptives; 12. Patients who have unsatisfied conpliance, can't understand the situation of the study and fail to sign the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function;Cancer pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune function;Solid tumor effect;overall survival;progression free survival;Clinical symptoms;PS scores;Tumor markers;Neutrophil/lymphocyte ratio; | — |
Countries
China
Contacts
Public ContactLin Lizhu
The First Affiliated Hospital of Guangzhou University of TCM
Outcome results
None listed