Status:
UNKNOWN
Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Eastern Hepatobiliary Surgery Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to compare the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with the anti-angiogenic targeted drugs and ginsenoside Rg3 versus TACE alone in...
Detailed Description
TACE is widely used in patients with unresectable HCC, which has been proved to significantly improve the survival time by the results from some randomized controlled studies and meta-analyses. Howeve...
Eligibility Criteria
Inclusion
- Aged 18-75
- Unresectable HCC patients clinically diagnosed or confirmed by histopathology and/or cytology according to Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition);
- At least one measurable lesion (according to mRECIST);
- BCLC stage B or C (China Liver Cancer Staging \[CNLC\] IIa, IIb and IIIa);
- The maximum diameter of a single lesion ≤10cm; No more than 10 lesions; or combined with portal vein thrombus (PVTT) type I and II (Cheng's classification);
- Child-pugh score \<7;
- Eastern Cooperative Oncology Group (ECOG) PS 0-1;
Exclusion
- Mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma (HCC-ICC) confirmed by pathology;
- Extrahepatic metastasis;
- Previously received hepatectomy, liver transplantation, interventional therapy, ablative therapy and other local therapies for HCC;
- PVTT type III/IV (Cheng's classification), major hepatic vein invasion or primary to secondary bile duct invasion;
- A history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding in the past 4 weeks;
- Cardiovascular diseases with significant clinical significance;
- Active infection;
- Other significant clinical and laboratory abnormalities that investigators believe affect safety evaluation.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04523467
Start Date
December 1 2020
End Date
December 31 2023
Last Update
August 21 2020
Active Locations (1)
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1
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, China, 200438