Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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 patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage B/C hepatocellular carcinoma (HCC), who has normal liver function and no extrahepatic metastasis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital
• Treatments: Angiogenesis Inhibitors; Ginsenoside Rg3

Criteria

Inclusion Criteria:

1. Aged 18-75

2. 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);

3. At least one measurable lesion (according to mRECIST);

4. BCLC stage B or C (China Liver Cancer Staging [CNLC] IIa, IIb and IIIa);

5. 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);

6. Child-pugh score <7;

7. Eastern Cooperative Oncology Group (ECOG) PS 0-1;

Exclusion Criteria:

1. Mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma (HCC-ICC) confirmed by pathology;

2. Extrahepatic metastasis;

3. Previously received hepatectomy, liver transplantation, interventional therapy, ablative therapy and other local therapies for HCC;

4. PVTT type III/IV (Cheng's classification), major hepatic vein invasion or primary to secondary bile duct invasion;

5. A history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding in the past 4 weeks;

6. Cardiovascular diseases with significant clinical significance;

7. Active infection;

8. Other significant clinical and laboratory abnormalities that investigators believe affect safety evaluation.