NCT06876753

Brief Summary

Tumor-draining lymph nodes play an important role in anti-tumor immune responses. In patients with hepatocellular carcinoma (HCC), however, the relationship between regional lymph node metastasis (LNM) and immunotherapy-based efficacy is unclear. This study aimed to evaluate whether extrahepatic LNM is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced HCC.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

June 1, 2018

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

7 years

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

hepatocellular carcinomalymph node metastasistransarterial chemoembolizationimmune checkpoint inhibitorsmolecular target therapies

Outcome Measures

Primary Outcomes (1)

  • Overall Survival(OS)

    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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    up to approximately 2 years

  • PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    up to approximately 2 years

  • Objective response rate(ORR) per RESCIST 1.1

    up to approximately 2 years

  • ORR per mRECIST

    up to approximately 2 years

  • Disease Control Rate (DCR) per RESCIST 1.1

    up to approximately 2 years

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metastatic HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions

You may qualify if:

  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
  • Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread;
  • Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
  • Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
  • TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
  • Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
  • Has repeated measurable intrahepatic lesions;

You may not qualify if:

  • Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  • Unable to meet criteria of combination timeframe described above;
  • Child-Pugh C or PS \> 2 or Severe hepatic encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhongda Hospital

Nanjing, Jiangsu, China

COMPLETED

Zhongda Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLymphatic Metastasis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gao-jun Teng, M.D

    Zhongda hospital, Southeast university, Nanjing, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, M.D

CONTACT

+86-02583272121gjteng@vip.sina.com

Hai-dong Zhu, M.D

CONTACT

+86-02583272121zhuhaidong9509@163.com

Study Design

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

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

June 1, 2018

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

CN(2)