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

NCT ID: NCT04523467

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-12-31

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

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. 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined group

Anti-angiogenic targeted drug + Rg3 + TACE

Group Type: EXPERIMENTAL

Anti-angiogenic Targeted Drugs

Intervention Type: DRUG

A tyrosine kinase inhibitor inhibits vascular endothelial growth factor (VEGF) receptors 1-3, showed efficacy in hepatocellular carcinoma

Ginsenoside Rg3

Intervention Type: DRUG

An active ingredient extracted from ginseng leachate, which can restrain angiogenesis and reduce the expression of programmed cell death ligand 1 (PD-L1) on the tumor cell surface and block the binding of programmed cell death 1 (PD-1) and PD-L1

TACE

Intervention Type: PROCEDURE

A specific type of chemoembolization that blocks the hepatic artery to treat liver cancer

Single group

TACE alone

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: PROCEDURE

A specific type of chemoembolization that blocks the hepatic artery to treat liver cancer

Interventions

Anti-angiogenic Targeted Drugs

A tyrosine kinase inhibitor inhibits vascular endothelial growth factor (VEGF) receptors 1-3, showed efficacy in hepatocellular carcinoma

Intervention Type: DRUG

Ginsenoside Rg3

An active ingredient extracted from ginseng leachate, which can restrain angiogenesis and reduce the expression of programmed cell death ligand 1 (PD-L1) on the tumor cell surface and block the binding of programmed cell death 1 (PD-1) and PD-L1

Intervention Type: DRUG

TACE

A specific type of chemoembolization that blocks the hepatic artery to treat liver cancer

Intervention Type: PROCEDURE

Other Intervention Names

TKI Drugs; Rg3

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shen Feng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Feng Shen, MD

Role: CONTACT

shenfengehbh@sina.com

+862181875005

Other Identifiers

EHBHKY2020-K-009

Identifier Type: -

Identifier Source: org_study_id