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.
Single group
Tumor Treating Fields
DeviceTumor treating fields will be used each day.
Durvalumab
DrugDurvalumab 1500 mg will be administrated via Intravenous (IV) infusion Once Every 3 weeks (Q3W) on day 1 of each cycle for up to 8 cycles. And then 1500 mg Once Every 4 weeks (Q4W) on day 1 of each cycle until confirmed progressive disease (PD).
Gemcitabine
DrugGemcitabine 1000 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
Cisplatin
DrugCisplatin 25 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
Progression-free survival (PFS)
PFS is defined as the time from the date of treatment until the date of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)-defined radiological PD or death.
Safety profile
Safety profile is defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments.
Objective response rate (ORR)
ORR is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).
Disease control rate (DCR)
DCR is defined as the rate of best objective response of CR, PR, or stable disease (SD).
Duration of response (DOR)
DOR is defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression.
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Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Lead sponsor
AstraZeneca
Collaborator
