Combination of TATE and PD-1 Inhibitor in Liver Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Colorectal Neoplasms
- Gastric Cancer
- Hepatocellular Carcinoma
- Lung Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: One arm for HCC, CRC, gastric cancer and NSCLC each. All enrolled patients will receive the same treatment with TATE and a PD-1 inhibitor until disease progressionMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The goal of the study is to investigate whether tumor necrosis induced by Trans-arterial Tirapazamine Embolization (TATE) treatment can boost anti-tumor immunity and enhance the therapeutic efficacy of immune checkpoint inhibitor. Patients with advanced liver cancers (primary HCC or metastatic liver...
The goal of the study is to investigate whether tumor necrosis induced by Trans-arterial Tirapazamine Embolization (TATE) treatment can boost anti-tumor immunity and enhance the therapeutic efficacy of immune checkpoint inhibitor. Patients with advanced liver cancers (primary HCC or metastatic liver cancer derived from colorectal, gastric and NSCLC) will be enrolled in the study. Liver lesions will be treated with up to 4 TATE treatments for optimal debulking, which also serve as a vaccination process toward tumor. Lesion not treated with TATE will be used for monitoring the response toward a PD-1 inhibitor (either Nivolumab or Pembrolizumab per investigator decision). If a patient subsequently develops an "escape" to the PD-1 inhibitor, patient can have another 2 TATE treatments of the escaped tumor lesion. Dosing of the PD-1 inhibitor is per standard FDA-approved dosing schedule and continues until progressive disease. The efficacy will be assessed by the response rate (RR) using RECIST and irRC for the non-TATE treated lesion, and compared with the historic RR of the PD-1 inhibitor in HCC (~16%) and mCRC (almost 0% for those without mismatch repair defect), advanced gastric cancer (15%) and metastatic NSCLC who failed to respond to an immune checkpoint inhibitor.
Tracking Information
- NCT #
- NCT03259867
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nadine Abi-Jaoudeh, MD UC Irvine Medical Center
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