Combination of TATE and PD-1 Inhibitor in Liver Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTeclison Ltd.
About this trial
This is a multi-center, open-label phase IIA study that investigates the preliminary efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer followed by a PD-1 checkpoint inhibitor (nivolumab). Patients with two types of cancers will be enrolled, advanced hepatocellular carcinoma (HCC),and metastatic gastric cancer. All enrolled patients need to have liver lesions and have progressed on a prior immune checkpoint inhibitor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.
Patients between ages 18 and 80
If HCC patients, they should have progressive disease (PD) on an immune therapy for advanced HCC. For patients with metastatic gastric cancer, they should have failed at least one line of systemic chemotherapy and an immune checkpoint inhibitor.
Patients with liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target lesion.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Nivolumab Injectable Product
Druga PD-1 immune check inhibitor
Trans-arterial tirapazamine embolization
Combination productEmbolization with Lipiodol and Gelfoam
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Advanced Hepatocellular carcinomaExperimental treatment 2 interventions
Group B: Metastatic Gastro-esophageal cancerExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall Response Rate
Per RECIST 1.1 criteria
Time frame
up to 24 monthsSecondary outcomes
1
Duration of Response
From the date of image-demonstrated response to the date of progression
Time frame
up to 24 months2
Time to Progression
From randomization to disease progression or death
Time frame
up to 24 months3
Progression Free Survival
From randomization to disease progression or death
Time frame
up to 24 months4
Overall survival
From randomization to death
Time frame
through study completion, an average of 3 yearsSponsors and contacts
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Source ClinicalTrials.gov