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

Last updated: April 22, 2024
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Biliary Tract Cancer

Liver Cancer

Digestive System Neoplasms

Treatment

Adebrelimab, Apatinib, Gemcitabine, cisplatin

Clinical Study ID

NCT06280508
SYSKY-2024-082-01
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of gastrointestinal hemorrhage within 6 months prior to the start of studytreatment or clear tendency of gastrointestinal hemorrhage
  • Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6months 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 studytreatment
  • Cardiac clinical symptom or disease that is not well controlled
  • Hypertension that can not be well controlled through antihypertensive drugs

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Adebrelimab, Apatinib, Gemcitabine, cisplatin
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 31, 2028

Connect with a study center

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

    Guangzhou, China/Guangdong
    China

    Active - Recruiting

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