A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
Trial Parameters
Brief Summary
Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis. This study is to evaluate the efficacy and safety of adding TTF to the established regimen of durvalumab plus GemCis for the treatment of patients with previously untreated, unresectable BTC.
Eligibility Criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent for the trial. 2. Male or female patients between the ages of 18 and 75 years (including 18 and 75 years). 3. Body weight \> 30 kg. 4. Histologically confirmed, unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. 5. Patients with the previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible. 6. Patients with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible (but he/she does not receive systemic treatment as the first-line therapy). 7. At least 1 measurable lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline. 8. ECOG PS of 0 or 1. 9. Life expectancy ≥12 weeks at the time of screening. 10. No prior exposure to immune-mediated therapy, including, but not limited to, other