A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

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

Treatment groups

604 Participants
are divided into 2 treatment groups