TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors (TIKET)

June 27, 2024 updated by: Haipeng Yu, Tianjin Medical University Cancer Institute and Hospital

Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors

This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The specific operation of TACE is based on the CSCO Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition). TACE is performed through microcatheters. After TACE, the coaxial catheter is retained in the hepatic artery or left or right hepatic artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for more than 4 hours on the first day. After HAIC is completed, remove the catheter and sheath. Repeat catheterization in the next treatment cycle.

Immune checkpoint inhibitors can be administered arterial starting after the first TACE treatment, q4w (± 3 days). If the situation requires, the arterial administration of ICI can be adjusted forward or backward for 7 days to adapt to TACE treatment.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Principal Investigator:
          • Haipeng Yu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
  • Sign informed consent
  • When screening for age, the age should be ≥ 18 years old
  • Eligible for TACE treatment
  • ECOG physical condition score is 0 or 1
  • No prior systemic therapy for HCC, especially immunotherapy
  • According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation

Exclusion Criteria:

  • Have any history of kidney disease or nephrotic syndrome
  • Evidence of extrahepatic spread (EHS)
  • Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control
  • Any condition representing a contraindication to TACE as determined by the investigators
  • Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding
  • Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment)
  • Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization)
  • Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TACE combined ICI
Procedure: TACE with ICI
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 3 years
Progression free survival
3 years
OS
Time Frame: 3 years
Overall Survival
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 3 years
Objective response rate
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTP
Time Frame: 3 years
Time to Progression (TTP) as Determined by Investigator
3 years
DOR
Time Frame: 3 years
Duration of Responses (DOR) as Determined by Investigator
3 years
AE
Time Frame: Baseline up to approximately 48 months
Percentage of Participants With Adverse Events
Baseline up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Estimated)

October 27, 2025

Study Completion (Estimated)

October 27, 2026

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCHIO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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