SHR-8068 with adebrelimab and platinum chemotherapy versus durvalumab with platinum chemotherapy for first-line advanced biliary tract cancer

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)

This trial tests whether SHR-8068 plus adebrelimab and platinum chemotherapy works better than durvalumab plus platinum chemotherapy as first treatment for people with advanced biliary tract cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: adbelimab, varicumab, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07229625 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, multicenter phase III trial compares SHR-8068 combined with adebrelimab and platinum-based chemotherapy against durvalumab combined with platinum-based chemotherapy as first-line therapy for inoperable locally advanced or metastatic biliary adenocarcinoma. Eligible patients have no prior systemic anti-tumor therapy, measurable disease per RECIST v1.1, and ECOG performance status 0–1. Participants receive gemcitabine and cisplatin with the assigned immunotherapy combination and are followed for efficacy and safety outcomes including response rates, progression-free survival, overall survival, and adverse events. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals and is enrolling at The First Affiliated Hospital, College of Medicine, Zhejiang University.

Who should consider this trial

Good fit: Ideal candidates are adults with inoperable locally advanced or metastatic biliary adenocarcinoma who have not received prior systemic therapy, have at least one measurable lesion, ECOG 0–1, and adequate organ function.

Not a fit: Patients with non-adenocarcinoma biliary tumors, other active malignancies, untreated biliary obstruction at risk of infection, active autoimmune disease, or prior systemic anti-tumor therapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could improve response rates and survival compared with current durvalumab-plus-chemotherapy first-line treatment, offering a new option for patients with advanced biliary tract cancer.

How similar studies have performed: Yes—previous trials combining immune checkpoint inhibitors with gemcitabine and cisplatin, notably durvalumab plus chemotherapy, have shown improved survival in first-line advanced biliary tract cancer, so this approach builds on existing positive data.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xin Shi

Conditions Advanced Biliary Tract Cancer