TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

TACE with ICI
Procedure/Surgery
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: TACE combined ICIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

PFS

Progression free survival

Time frame

3 years

Overall Survival

Time frame

3 years

Secondary outcomes

ORR

Objective response rate

Time frame

3 years

Other outcomes

TTP

Time to Progression (TTP) as Determined by Investigator

Time frame

3 years

DOR

Duration of Responses (DOR) as Determined by Investigator

Time frame

3 years

Percentage of Participants With Adverse Events

Time frame

Baseline up to approximately 48 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

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