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.
Willing and able to provide written informed consent for the trial.
Male or female patients between the ages of 18 and 75 years (including 18 and 75 years).
Body weight > 30 kg.
Histologically confirmed, unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
Patients previously received systemic treatment as the first-line therapy.
Ampullary carcinoma.
History of allogeneic organ transplantation.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto syndrome) are stable on hormone replacement; Any chronic skin condition that does not require systemic therapy; Patients without active disease in the last 5 years may be included but only after consultation with the investigator/ Study Physician; Patients with celiac disease controlled by diet alone.
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Lead sponsor
AstraZeneca
Collaborator