A new phase 2 clinical trial testing the feasibility and safety of the combination of tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment in patients with intrahepatic cholangiocarcinoma (iCCA) is now open.
The study aims to determine the conversion rate of unresectable tumors to resectable cancer with the treatment. The investigation also evaluates the side effects of the treatment.
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The trial, which is not yet recruiting participants, aims to enroll 28 patients who are 18 years of age or older, with histologically proven iCCA who are untreated with systemic therapy.
The participants will have an initial tumor biopsy and undergo imaging and laboratory studies before the start of treatment. They will then continue for 4 cycles of durvalumab, tremelimumab, gemcitabine, and cisplatin treatment, and if the tumor is resectable, undergo surgery.
If the tumor is not resectable after the 4 cycles, participants will receive 4 more cycles and undergo more imaging tests. If the tumor is still unresectable, the patients will be treated with capecitabine for up to 8 cycles and durvalumab for up to a year.
The primary outcome measures of the trial are the rate of conversion of the tumor from unresectable to resectable and the incidence of treatment-emergent adverse events.
Secondary outcome measures are the pathological complete response, overall objective response rate, event-free survival, progression-free survival, relapse-free survival, rate of R0 resection, and patient-reported outcomes.
The trial, sponsored by Georgetown University and Astra Zeneca, is expected to start in November 2023 and end in November 2026.
CCA is a heterogeneous group of rare malignant tumors originating from cells of the biliary tree. iCCA is located inside the hepatic parenchyma and has particularly high mortality rates.
Reference
Neoadjuvant tremelimumab and durvalumab with Gem/Cis in intrahepatic cholangiocarcinoma (ESR-22-21719). US National Library of Medicine. Updated August 30, 2023. Accessed September 6, 2023.
