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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE; Drug: Anti-angiogenic Targeted Drugs; Drug: Ginsenoside Rg3

Study type: Interventional

Funder types: Other

Identifiers

NCT04523467

EHBHKY2020-K-009

Details and patient eligibility

About

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.

Full 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. However, due to the different blood supply characteristics and biological heterogeneity in HCC nodules, the therapeutic effect of TACE is limited, and which is still considered as a non-radical treatment. Furthermore, vascular embolization by TACE may result in hypoxia in tumor tissue, which will induce increased secretion of angiogenic factors such as vascular endothelial growth factor (VEGF) and tumor angiogenesis, promote proliferation of residual tumor cells, and enhance tumor invasive and metastasis. Accordingly, the effectiveness of TACE is still unsatisfying as a single treatment for HCC.

Both anti-angiogenic targeted drugs and ginsenoside Rg3 have showed synergistic effect with TACE in patients with unresectable HCC. The purpose of this trial is to evaluate the efficacy and safety of the combination of anti-angiogenic targeted drugs and ginsenoside Rg3 plus TACE comparing to TACE alone in patients with unresectable HCC.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Combined group

Experimental group

Description:

Anti-angiogenic targeted drug + Rg3 + TACE

Treatment:

Drug: Ginsenoside Rg3

Procedure: TACE

Drug: Anti-angiogenic Targeted Drugs

Single group

Active Comparator group

Description:

TACE alone

Treatment:

Procedure: TACE