Combination of TATE and PD-1 Inhibitor in Liver Cancer (TATE-PD1)
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ClinicalTrials.gov Identifier: NCT03259867 |
Recruitment Status :
Recruiting
First Posted : August 24, 2017
Last Update Posted : April 21, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma Gastric Cancer | Drug: Nivolumab Injectable Product Combination Product: Trans-arterial tirapazamine embolization | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | One arm for advanced HCC, and one for second line metastatic gastro-esophageal cancer . All enrolled patients will receive the same treatment with TATE and a PD-1 inhibitor (nivolumab) until disease progression |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | May 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Advanced Hepatocellular carcinoma
PD-1 inhibitor (Nivolumab 480 mg Q4W 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. |
Drug: Nivolumab Injectable Product
a PD-1 immune check inhibitor
Other Name: OPDIVO Combination Product: Trans-arterial tirapazamine embolization Embolization with Lipiodol and Gelfoam |
Experimental: Metastatic Gastro-esophageal cancer
PD-1 inhibitor (Nivolumab 480 mg Q4W 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. |
Drug: Nivolumab Injectable Product
a PD-1 immune check inhibitor
Other Name: OPDIVO Combination Product: Trans-arterial tirapazamine embolization Embolization with Lipiodol and Gelfoam |
- Overall Response Rate [ Time Frame: up to 24 months ]Per RECIST 1.1 criteria
- Duration of Response [ Time Frame: up to 24 months ]From the date of image-demonstrated response to the date of progression
- Time to Progression [ Time Frame: up to 24 months ]From randomization to disease progression or death
- Progression Free Survival [ Time Frame: up to 24 months ]From randomization to disease progression or death
- Overall survival [ Time Frame: through study completion, an average of 3 years ]From randomization to death

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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 the first line 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 at least two 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. Alternatively, patients with one intra-hepatic lesion of 2 cm or bigger and exhapetic lesion(s) are also acceptable.
- ECOG score 2 or less
- Child-Pugh scores 5-7 for HCC patients
- Patients have normal organ function.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259867
Contact: Ray Lee, MD PhD | 8043341076 | ray.lee01@teclison.com |
United States, California | |
University of California, Irvine | Recruiting |
Orange, California, United States, 92868 | |
Contact: Cindy D Duong | |
Principal Investigator: Nadine Abi-Jaoudeh, MD |
Principal Investigator: | Nadine Abi-Jaoudeh, MD | UC Irvine Medical Center |
Responsible Party: | Teclison Ltd. |
ClinicalTrials.gov Identifier: | NCT03259867 |
Other Study ID Numbers: |
LT-004 |
First Posted: | August 24, 2017 Key Record Dates |
Last Update Posted: | April 21, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatocellular carcinoma Immune checkpoint inhibitor Gastric cancer Progression |
Carcinoma, Hepatocellular Stomach Neoplasms Liver Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Liver Diseases Gastrointestinal Neoplasms Gastrointestinal Diseases Stomach Diseases Nivolumab Tirapazamine Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |