NCT07836309

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with Tislelizumab and Lenvatinib in patients with advanced-stage hepatocellular carcinoma (HCC).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
596

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Dec 2027

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

TACETislelizumabLenvatinibHCC

Outcome Measures

Primary Outcomes (1)

  • Overall Survival(OS)

    The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

    up to approximately 2 years

Secondary Outcomes (9)

  • Progression free survival(PFS) per RECIST 1.1

    up to approximately 2 years

  • PFS per mRECIST

    up to approximately 2 years

  • Objective response rate(ORR) per RESCIST 1.1

    up to approximately 2 years

  • Duration of Response (DOR) per RESCIST 1.1

    up to approximately 2 years

  • Disease Control Rate (DCR) per RESCIST 1.1

    up to approximately 2 years

  • +4 more secondary outcomes

Study Arms (2)

Study group

TACE + Tislelizumab + Lenvatinib TACE was performed within 3 months before or after the first Tislelizumab /Lenvatinib treatment. The interval between first use Tislelizumab and Lenvatinib ≤1 week；

Control group

Tislelizumab + Lenvatinib The interval between first use Tislelizumab and Lenvatinib ≤1 week；

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced HCC who received Tislelizumab and Lenvatinib with/without TACE under real-world practice conditions.

You may qualify if:

  • Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients who meet the clinical diagnostic criteria for primary liver cancer;
  • Age ≥18 years at the time of HCC diagnosis;
  • Barcelona Clinic Liver Cancer (BCLC) stage C;
  • No prior systemic therapy for HCC (including chemotherapy, molecular targeted therapy, or immunotherapy);
  • Received treatment with tislelizumab and lenvatinib, with the interval between the first administration of the two drugs ≤1 week;
  • In the experimental group, TACE was performed within 3 months before or after treatment with tislelizumab and lenvatinib;
  • After TACE, patients received at least one cycle of combination therapy with tislelizumab and lenvatinib, including cTACE and DEB-TACE;
  • Child-Pugh class A5 to B7;
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
  • At least one measurable intrahepatic lesion according to RECIST 1.1 criteria.

You may not qualify if:

  • Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma histological types;
  • Complete obstruction of the main portal vein with insufficient collateral compensation;
  • Uncontrollable ascites or hepatic encephalopathy;
  • Incomplete clinical data or missing essential information;
  • Presence of other primary malignant tumors in addition to the diagnosis of liver cancer;
  • Participation in other interventional studies prior to treatment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhicheng Jin, M.D., Ph.D.

CONTACT

+86-025-83272121jinzhic@foxmqil.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Prof. , President

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)