NCT06181032

A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies

A Single-arm Prospective Clinical Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin for the Neoadjuvant Treatment of Biliary Tract Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of patients with biliary tract malignancies.

Detailed description

Existing immune-combination chemotherapy has shown excellent data in advanced biliary malignancies, so what is the efficacy and safety of this regimen in neoadjuvant therapy? Moreover, the current combination model of immunization combined with anti-angiogenic drugs has become another new direction in the field of solid tumor treatment. Therefore, our group designed a single-arm, prospective clinical study of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of biliary malignancies, aiming at evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of biliary malignancies in patients with a view to bringing longer-term benefits to patients with resectable biliary malignancies.

Conditions

• Biliary Tract Malignancies

Interventions

Type	Name	Description
DRUG	Adebrelimab	Adebrelimab: 1200mg or 20mg/kg, iv, D1, Q3W;
DRUG	Apatinib	Apatinib: 250 mg, po, QD, Q3W;
DRUG	Gemcitabine	Gemcitabine: 1000 mg/m2, iv, 30min, D1, D8, Q3W;
DRUG	Cisplatin	Cisplatin: 25 mg/m2, iv, 30min, D1, D8, Q3W; Injection sequence: adebelizumab → gemcitabine → cisplatin (sequential interval of at least 30 min), 3 cycles of neoadjuvant therapy.

Timeline

• Start date: 2023-12-23
• Primary completion: 2029-02-23
• Completion: 2029-02-23
• First posted: 2023-12-26
• Last updated: 2024-04-30

Locations

1 site across 1 country: China