NCT04523467

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

August 18, 2020

Last Update Submit

August 19, 2020

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    the time from randomization to documented progression

    Up to 2 years

Secondary Outcomes (4)

  • Time to TACE untreated progression

    Up to 2 years

  • Objective response rate

    Up to 2 years

  • Overall survival

    Up to 2 years

  • Adverse events

    Up to 2 years

Other Outcomes (1)

  • Conversion rate

    Up to 2 years

Study Arms (2)

Combined group

EXPERIMENTAL

Anti-angiogenic targeted drug + Rg3 + TACE

Drug: Anti-angiogenic Targeted DrugsDrug: Ginsenoside Rg3Procedure: TACE

Single group

ACTIVE COMPARATOR

TACE alone

Procedure: TACE

Interventions

Anti-angiogenic Targeted DrugsDRUG

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

Also known as: TKI Drugs
Combined group
Ginsenoside Rg3DRUG

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

Also known as: Rg3
Combined group
TACEPROCEDURE

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

Combined groupSingle group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

ginsenoside Rg3

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Feng Shen, MD

CONTACT

+862181875005shenfengehbh@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 21, 2020

Study Start

December 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

CN(1)