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NCT Number: NCT07229625

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)

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.

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Key information

Conditions

Advanced Biliary Tract Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-8068 Injection

Drug

SHR-8068 injection.

Adebrelimab Injection

Drug

Adebrelimab injection.

Gemcitabine Hydrochloride for Injection

Drug

Gemcitabine Hydrochloride for injection.

Cisplatin injection

Drug

Cisplatin injection.

Durvalumab Injection

Drug

Durvalumab injection.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 15 months.

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: Up to 7 months.

  2. Duration of Response (DoR)

    Time frame: Up to 7 months.

  3. Progression free Survival (PFS)

    Time frame: Up to 7 months.

  4. Objective Response Rate (ORR)

    Time frame: Up to 7 months.

  5. Time to Progression (TTP)

    Time frame: Up to 7 months.

  6. Time to Response (TTR)

    Time frame: Up to 7 months.

  7. Adverse events (AEs)

    Time frame: Up to approximately 15 months.

  8. Serious adverse events (SAEs)

    Time frame: Up to approximately 15 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Shi

CONTACT

[email protected]

+86-0518-82342973

Xin Xu

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 17, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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