RecruitingPhase 2NCT06280508

Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer

A Prospective, Single-arm Exploratory Trail of Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

40 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • confirmed intrahepatic cholangiocarcinoma
  • with Resectable tumor lesion
  • no contraindications to surgery
  • with high risk of tumour recurrence
  • No prior systemic therapy for intrahepatic cholangiocarcinoma.
  • ECOG Performance Status of 0 or 1
  • Child-Pugh Class: Grade A

Exclusion Criteria6

  • History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
  • Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
  • Known genetic or acquired hemorrhage or thrombotic tendency
  • Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
  • Cardiac clinical symptom or disease that is not well controlled
  • Hypertension that can not be well controlled through antihypertensive drugs

Interventions

DRUGAdebrelimab, Apatinib, Gemcitabine, cisplatin

Chemotherapy combined with Adebrelimab and Apatinib neoadjuvant therapy for 3 cycles before surgery, and Adebrelimab combined with Apatinib adjuvant therapy for 6 months after surgery


Locations(1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, China/Guangdong, China

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NCT06280508