September 2024, Vol 5, No 3

We are highlighting several key areas of clinical research in this issue of CCA News. The role of radiation therapy in locally advanced intrahepatic cholangiocarcinoma (iCCA) has been established in single-arm phase 2 trials; however, there is a lack of randomized controlled data.

Efficacy and safety results from the randomized phase 2 ABC-07 trial was presented comparing the addition of stereotactic body radiotherapy (SBRT) to systemic chemotherapy in patients with locally advanced cholangiocarcinoma (CCA).

The phase 2 BOLD-100-001 study evaluated the safety and efficacy of the novel BOLD-100 anticancer drug plus FOLFOX chemotherapy in patients with pretreated advanced biliary tract cancer (BTC).

The updated efficacy and safety data of KEYNOTE-966 were presented at ASCO 2024 comparing pembrolizumab plus gemcitabine and cisplatin (gem/cis) with gem/cis alone for patients with advanced biliary tract cancer (BTC).

An investigation in phase 2 was carried out to assess the efficacy of combining atezolizumab and varlilumab with or without cobimetinib in patients with unresectable biliary tract cancer (BTC) who had been previously treated.

A phase 2 clinical trial was conducted to evaluate the effectiveness of sitravatinib and tislelizumab combination therapy in treating advanced biliary tract cancer (BTC) in patients who have not had success with at least 1 prior systemic treatment.

The efficacy and safety of trastuzumab deruxtecan were evaluated in patients with HER2-expressing biliary tract cancer in the DESTINY-PanTumor02 (DP-02) study.

Results from the ongoing phase 2b HERIZON-BTC-01 study evaluating the efficacy and safety of zanidatamab in patients with previously treated HER2-positive biliary tract cancer were presented at ASCO 2024.

The efficacy and safety of erdafitinib in patients with advanced or metastatic CCA and FGFR alterations from a pooled analysis of the RAGNAR and LUC2001 studies were presented at ASCO 2024.

The phase 1b regional immuno-oncology trial, PERIO-02, investigated the effects of nelitolimod (SD-101), a class C TLR9 agonist, delivered via hepatic artery infusion along with checkpoint inhibition in patients with intrahepatic cholangiocarcinoma (iCCA) and hepatocellular carcinoma (HCC).