Combination of TATE and PD-1 Inhibitor in Liver Cancer

Part of paid clinical trials in Orange, California.

Sponsor
Teclison Ltd.
Study ID
NCT03259867
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab Injectable Product — DRUG
    a PD-1 immune check inhibitor
  • Trans-arterial tirapazamine embolization — COMBINATION_PRODUCT
    Embolization with Lipiodol and Gelfoam

Study Details

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.

Key Dates

Start date
Jul 1, 2017
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced Hepatocellular carcinoma
    PD-1 inhibitor (Nivolumab 360 mg Q3W IV ) starts at day 1, and continues until progression. TATE treatment starts at day 8 for debulking up to 4 cycles. If escape lesion appears, two more TATE treatments can be given. Tirapazamine dose at 35 mg flat dose given before embolization.
  • Experimental: Metastatic Gastro-esophageal cancer
    PD-1 inhibitor (Nivolumab 360 mg Q3W IV) starts at day 1, and continues until progression. TATE treatment starts at day 8 for debulking up to 4 cycles. If escape lesion appears, two more TATE treatments can be given. Tirapazamine dose at 35 mg flat dose given before embolization.

Primary Outcome Measure

Overall Response Rate [ Time Frame: up to 24 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, IrvineOrangeCalifornia92868
Miranda Duron
[email protected]
Nadine Abi-Jaoudeh, MD (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Science CenterOklahoma CityOklahoma73104
Melissa Yarbrough, RN
[email protected]
Medical College of WisconsinMilwaukeeWisconsin53226
Barbara Dion
[email protected]

Find similar trials in Orange, CA

By condition
Gastric cancerLiver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of California, Irvine· Orange, CAUniversity of Oklahoma Health Science Center· Oklahoma City, OKMedical College of Wisconsin· Milwaukee, WI

Related Studies