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

Primary Purpose

Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anti-angiogenic Targeted Drugs
Ginsenoside Rg3
TACE
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined group

Single group

Arm Description

Anti-angiogenic targeted drug + Rg3 + TACE

TACE alone

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
the time from randomization to documented progression

Secondary Outcome Measures

Time to TACE untreated progression
the time from randomization to TACE untreatable progression
Objective response rate
The proportion of patients whose tumor volume has decreased to a predetermined value
Overall survival
The time period from the randomization of the patient to the death event due to any reason
Adverse events
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

Full Information

First Posted
August 18, 2020
Last Updated
August 19, 2020
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04523467
Brief Title
Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma
Official Title
A Multicentre Randomized Controlled Study of Anti-angiogenic Targeted Drugs Combined With Ginsenoside Rg3 to Improve the Efficacy of Transcatheter Arterial Chemoembolization (TACE) in the Treatment of Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined group
Arm Type
Experimental
Arm Description
Anti-angiogenic targeted drug + Rg3 + TACE
Arm Title
Single group
Arm Type
Active Comparator
Arm Description
TACE alone
Intervention Type
Drug
Intervention Name(s)
Anti-angiogenic Targeted Drugs
Other Intervention Name(s)
TKI Drugs
Intervention Description
A tyrosine kinase inhibitor inhibits vascular endothelial growth factor (VEGF) receptors 1-3, showed efficacy in hepatocellular carcinoma
Intervention Type
Drug
Intervention Name(s)
Ginsenoside Rg3
Other Intervention Name(s)
Rg3
Intervention Description
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
Procedure
Intervention Name(s)
TACE
Intervention Description
A specific type of chemoembolization that blocks the hepatic artery to treat liver cancer
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
the time from randomization to documented progression
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Time to TACE untreated progression
Description
the time from randomization to TACE untreatable progression
Time Frame
Up to 2 years
Title
Objective response rate
Description
The proportion of patients whose tumor volume has decreased to a predetermined value
Time Frame
Up to 2 years
Title
Overall survival
Description
The time period from the randomization of the patient to the death event due to any reason
Time Frame
Up to 2 years
Title
Adverse events
Description
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
Time Frame
Up to 2 years
Other Pre-specified Outcome Measures:
Title
Conversion rate
Description
The proportion of patients whose tumor has changed from unresectable to resectable after Intervention
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Shen, MD
Phone
+862181875005
Email
shenfengehbh@sina.com
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

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

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