Study on Combining TATE and PD-1 Inhibitor for Liver Cancer

Sponsor: Teclison Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03259867

Provider View

This clinical trial is exploring a new treatment approach for liver cancer by combining a procedure called Trans-arterial Tirapazamine Embolization (TATE) with a PD-1 inhibitor drug, nivolumab. The study includes patients with advanced liver cancer or liver metastases from gastric cancer who have not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to see if a treatment called Trans-arterial Tirapazamine Embolization (TATE) can help improve the effectiveness of a PD-1 inhibitor drug, nivolumab, in treating liver cancer. The study involves patients with advanced liver cancer or liver metastases from gastric cancer who have not responded to previous immune checkpoint inhibitor treatments. TATE is used to treat liver tumors and may help the immune system fight cancer more effectively. The study will monitor how well the cancer responds to this combination treatment.

Description

This study is testing a new way to treat liver cancer by combining two treatments: Trans-arterial Tirapazamine Embolization (TATE) and a PD-1 inhibitor drug called nivolumab. TATE is a procedure that targets liver tumors directly, which may help the immune system attack the cancer more effectively. Patients with advanced liver cancer or liver metastases from gastric cancer who have not responded to previous treatments are eligible to participate.

Participants will receive up to four TATE treatments to target liver tumors, which may also help the immune system recognize and fight the cancer. Tumors not treated with TATE will be monitored to see how they respond to nivolumab, which is given according to the standard dosing schedule. If the cancer starts to grow again despite treatment, patients may receive up to two additional TATE treatments.

The study will evaluate how well the cancer responds to this combination treatment by measuring the response rate using standard criteria. The goal is to see if this approach can improve outcomes for patients with liver cancer.

Eligibility Criteria

  1. Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.

  2. Patients between ages 18 and 80

  3. 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.

  4. 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.

  5. ECOG score 2 or less

  6. Child-Pugh scores 5-7 for HCC patients

  7. All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not subject to this limitation.

  8. No major GI bleeding in the prior 2 months.

  9. Hgb>=8, platelet >= 50,000, Cr =< 2, AST and ALT < 10 X ULN, t-Bilirubin < 3, 9. Patients with a history of major autoimmune disorders excluded.

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