TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

NCT ID: NCT06487663

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2026-10-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Non-resectable Cholangiocarcinoma Non-resectable Liver Metastases Liver Malignant Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TACE combined ICI

TACE combined ICI

Group Type EXPERIMENTAL

TACE with ICI

Intervention Type PROCEDURE

Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors

Interventions

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TACE with ICI

Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Haipeng Yu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haipeng Yu

Role: CONTACT

022-23340123 ext. 2701

Facility Contacts

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Yu Zheng

Role: primary

0086-22-23340123

Other Identifiers

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TCHIO-001

Identifier Type: -

Identifier Source: org_study_id

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