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)

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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07229625

Enrollment

604

Registered

2025-11-17

Start date

2026-01-21

Completion date

2029-12-01

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Biliary Tract Cancer

Brief summary

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

DRUGSHR-8068 Injection

SHR-8068 injection.

DRUGAdebrelimab Injection

Adebrelimab injection.

DRUGGemcitabine Hydrochloride for Injection

Gemcitabine Hydrochloride for injection.

DRUGCisplatin Injection

Cisplatin injection.

DRUGDurvalumab Injection

Durvalumab injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology; 2. No previous systemic anti-tumor treatment has been received; 3. At least one measurable lesion that complies with the RECIST v1.1 standard; 4. ECOG PS score: 0-1 point; 5. The expected survival period is ≥ 3 months; 6. Good organ function level; 7. Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements; 8. Patients voluntarily joined this study and signed informed consent.

Exclusion criteria

1. Other pathological types of cholangiocarcinoma other than adenocarcinoma; 2. Malignant tumor of the ampulla; 3. Have had or concurrently suffered from other malignant tumors; 4. Those with concurrent biliary obstruction and at risk of biliary tract infection; 5. Those with any active or known autoimmune diseases.

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	Up to 15 months.

Secondary

Measure	Time frame
Disease Control Rate (DCR)	Up to 7 months.
Duration of Response (DoR)	Up to 7 months.
Progression free Survival (PFS)	Up to 7 months.
Objective Response Rate (ORR)	Up to 7 months.
Time to Progression (TTP)	Up to 7 months.
Time to Response (TTR)	Up to 7 months.
Adverse events (AEs)	Up to approximately 15 months.
Serious adverse events (SAEs)	Up to approximately 15 months.

Countries

China

Contacts

CONTACTXin Shi

xin.shi.xs3@hengrui.com+86-0518-82342973

CONTACTXin Xu

xin.xu@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026