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)

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Advanced Biliary Tract Cancer

Treatments: Drug: SHR-8068 Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Adebrelimab Injection; Drug: Cisplatin Injection; Drug: Durvalumab Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229625

SHR-8068-303

Details and patient eligibility

About

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.

Enrollment: 604 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

604 participants in 2 patient groups

SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group

Experimental group

Treatment:

Drug: Cisplatin Injection

Drug: Adebrelimab Injection

Drug: Gemcitabine Hydrochloride for Injection

Drug: SHR-8068 Injection

Durvalumab + Cisplatin and Gemcitabine Group

Active Comparator group

Treatment:

Drug: Durvalumab Injection

Drug: Cisplatin Injection

Drug: Gemcitabine Hydrochloride for Injection