{"entity":{"id":"trap-btc","kind":"trial","name":"TRAP-BTC","aka":[],"tldr":"A small German study giving trastuzumab and pembrolizumab together with standard chemotherapy as the first treatment for HER2-positive bile duct or gallbladder cancer.","summary":"TRAP-BTC (NCT06178445) is a single-arm phase 2 at eight German sites for patients with histologically confirmed cholangiocarcinoma or gallbladder cancer that is HER2-positive and previously untreated, who receive standard gemcitabine and cisplatin with trastuzumab and pembrolizumab. The primary endpoint is objective response rate; 24 patients are planned, the trial opened in April 2024, is active but no longer recruiting, and lists primary completion in December 2026. It tests HER2 antibody plus checkpoint blockade on the chemotherapy backbone in a population in which gallbladder cancer is expected to predominate, ahead of the randomised HERIZON-BTC-302 and DESTINY-BTC01 trials.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06178445","url":"https://clinicaltrials.gov/study/NCT06178445"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["monoclonal-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":["her2","pd1"],"drugs":["trastuzumab","pembrolizumab","gemcitabine-cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06178445","phase":"2","setting":"Previously untreated HER2-positive biliary tract cancer (cholangiocarcinoma or gallbladder cancer): gemcitabine and cisplatin with trastuzumab and pembrolizumab, single arm, primary endpoint objective response rate","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","enrolled":24,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/trap-btc/","neighbours":{"cancer":[{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"term":[{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"}]}}