About this trial
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.
Eligibility criteria
Qualifiers
Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
No previous systemic anti-tumor treatment has been received;
At least one measurable lesion that complies with the RECIST v1.1 standard;
ECOG PS score: 0-1 point;
Disqualifiers
Other pathological types of cholangiocarcinoma other than adenocarcinoma;
Malignant tumor of the ampulla;
Have had or concurrently suffered from other malignant tumors;
Those with concurrent biliary obstruction and at risk of biliary tract infection;
Trial design
Treatments tested in this trial
- SHR-8068 Injection
- Adebrelimab Injection
- Gemcitabine Hydrochloride for Injection
- Cisplatin Injection
- Durvalumab Injection