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

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Anti-angiogenic Targeted Drugs; Drug: Ginsenoside Rg3; Procedure: TACE

• Registration Number: NCT04523467
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Study First Posted: 2020-08-21
• Last Update Posted: 2020-08-21
• Study Start: 2020-12-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined group	Anti-angiogenic Targeted Drugs	Anti-angiogenic targeted drug + Rg3 + TACE
Combined group	TACE	Anti-angiogenic targeted drug + Rg3 + TACE
Single group	TACE	TACE alone
Combined group	Ginsenoside Rg3	Anti-angiogenic targeted drug + Rg3 + TACE

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 2 years	the time from randomization to documented progression

Secondary Outcome Measures

Name	Time	Method
Objective response rate	Up to 2 years	The proportion of patients whose tumor volume has decreased to a predetermined value
Time to TACE untreated progression	Up to 2 years	the time from randomization to TACE untreatable progression
Overall survival	Up to 2 years	The time period from the randomization of the patient to the death event due to any reason
Adverse events	Up to 2 years	The severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard the severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard the severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China