This phase II trial studies how well gemcitabine, cisplatin and durvalumab/Pembrolizumab and surufatinib work in treating participants with advanced Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Whether if adding surufatinib to a standard of care can bring addition benefit needs to be explored.
Patients with biliary tract cancer who are clearly diagnosed by pathology, are unable to undergo radical surgery or have local/distant metastasis (allowing surgical treatment after successful transformation).
Have at least 1 lesion that can be measured according to RECIST v1.1 (more than 1cm on CT or MRI).
Have not received systematic anti-tumor therapy before.
Expected survival greater than 3 months;
Join another clinical study at the same time, unless it is during the follow-up period of an observational (non-interventional) or supportive care clinical study or interventional study.
Obstructive jaundice (bilirubin > 1.5 ULN) with inadequate biliary drainage.
Absolute neutrophil count (ANC) <1×109/L or platelet <80×109/L or hemoglobin < 8g/dL (based on the normal value of the clinical trial center)
Serum total bilirubin was 5 times higher than the upper limit of the normal reference range;
Dai, Guanghai
Lead sponsor
Chinese PLA General Hospital
Sponsor institution