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Clinical Trials in China / NCT07229625
Recruiting Phase 3

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)

NCT07229625 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd
Phase
Phase 3
Started
2026-01-21
Last updated
2026-01-28

Condition(s) studied

Advanced Biliary Tract Cancer

Investigational drug(s) / intervention(s)

SHR-8068 Injection →Adebrelimab Injection →Gemcitabine Hydrochloride for Injection →Cisplatin Injection →Durvalumab Injection →

SHR-8068 Injection: SHR-8068 injection.

Adebrelimab Injection: Adebrelimab injection.

Gemcitabine Hydrochloride for Injection: Gemcitabine Hydrochloride for injection.

Cisplatin Injection: Cisplatin injection.

Durvalumab Injection: Durvalumab injection.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall Survival (OS) — Up to 15 months.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan Active, not recruiting
A Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma Recruiting
Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Recruiting
A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer Recruiting
A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors Active, not recruiting

Other trials for the same condition

A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer Recruiting
Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment Active, not recruiting
Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer Recruiting
GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1） Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07229625 on ClinicalTrials.gov ↗ ← All trials in China