NCT05420922

Brief Summary

China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

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

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

10 months

First QC Date

May 26, 2022

Last Update Submit

June 11, 2022

Conditions

Hepatocellular CarcinomaProgrammed Cell Death 1Effects of Immunotherapy

Keywords

LenvatinibSorafenibProgrammed Cell Death 1Real-world studytranscatheter arterial chemoembolization

Outcome Measures

Primary Outcomes (3)

  • The objective response rate (ORR)

    ORR in three groups were compared

    8 weeks

  • The overall survival (OS)

    1 year OS in three groups were compared

    12 months

  • The treatment-related adverse events (TRAEs)

    Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0

    12 months

Secondary Outcomes (1)

  • The progression-free survival (PFS)

    8 weeks

Study Arms (3)

Systemic therapy

ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)

Drug: Lenvatinib Oral ProductDrug: PD-1 inhibitor

Local treatment

local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Procedure: Local treatment

Triple therapy

Systemic therapy plus Local treatment: ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc)

Drug: Lenvatinib Oral ProductDrug: PD-1 inhibitorProcedure: Local treatment

Interventions

Lenvatinib Oral ProductDRUG

Lenvatinib or Sorafenib

Systemic therapyTriple therapy
PD-1 inhibitorDRUG

Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1

Systemic therapyTriple therapy
Local treatmentPROCEDURE

Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Local treatmentTriple therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hepatocellular carcinoma patients using ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib), ICIs plus TKIs with local therapy (TACE, HAIC, RF ablation, microwave ablation, etc), local therapy only

You may qualify if:

  • Clinical diagnosis of hepatocellular carcinoma
  • Treated with ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib)
  • Treated with local therapy (TACE, HAIC, RF ablation, microwave ablation, radiotherapy, etc)
  • Treated Treated with ICIs plus TKIs and local therapy
  • Have complete medical record that can complete the OR or 1 year OS assessment and follow-up.

You may not qualify if:

  • Patients who do not have complete medical record and follow-up information after treatment；
  • The researchers have evidence that it is not suitable for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

Study Officials

  • Xiaoping Chen, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changhai Li, Doctor

CONTACT

8613986231269tjlichanghai@126.com

Xiaoping Chen

CONTACT

+862783663400chenxp@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 15, 2022

Study Start

November 1, 2021

Primary Completion

August 30, 2022

Study Completion

December 31, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

CN(1)