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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-8068 Injection, Adebrelimab Injection, Gemcitabine Hydrochloride for Injection, Cisplatin Injection.
- Who it may be relevant to
- Registry conditions: Advanced Biliary Tract Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase III, Randomized, Controlled, Open-Label, Multicenter 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)
Overview
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.
Interventions
- Drug SHR-8068 Injection
SHR-8068 injection. - Drug Adebrelimab Injection
Adebrelimab injection. - Drug Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection. - Drug Cisplatin Injection
Cisplatin injection. - Drug Durvalumab Injection
Durvalumab injection.
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to 15 months.]
Secondary outcome measures (8)
- Disease Control Rate (DCR) [Time frame: Up to 7 months.]
- Duration of Response (DoR) [Time frame: Up to 7 months.]
- Progression free Survival (PFS) [Time frame: Up to 7 months.]
- Objective Response Rate (ORR) [Time frame: Up to 7 months.]
- Time to Progression (TTP) [Time frame: Up to 7 months.]
- Time to Response (TTR) [Time frame: Up to 7 months.]
- Adverse events (AEs) [Time frame: Up to approximately 15 months.]
- Serious adverse events (SAEs) [Time frame: Up to approximately 15 months.]
Eligibility criteria
Inclusion criteria
- 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;
- The expected survival period is ≥ 3 months;
- Good organ function level;
- Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
- Patients voluntarily joined this study and signed informed consent.
Exclusion criteria
- 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;
- Those with any active or known autoimmune diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT07229625 · SHR-8068-303