PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone as the first line treatment for advanced biliary tract cancer: a pooled analysis of KEYNOTE-966 and TOPAZ-1 trails.

Background: The efficacy of PD-1/PD-L1 inhibitors plus chemotherapy (PIC) as a first-line treatment for advanced biliary tract cancer (BTC) remains controversial, given inconsistent findings regarding survival benefits and safety concerns. This meta-analysis systematically evaluates the safety and efficacy of PIC versus chemotherapy alone, aiming to provide more definitive guidance for BTC treatment decisions.

Methods: To identify phase 3 randomized controlled trials (RCTs) comparing PIC with chemotherapy alone in patients with advanced BTC, a comprehensive literature search was conducted across six databases.