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

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Sun Yat-sen University

Status and phase

Enrolling
Phase 2

Conditions

Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence

Treatments

Drug: Adebrelimab, Apatinib, Gemcitabine, cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT06280508
SYSKY-2024-082-01

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

treatment arm
Experimental group
Treatment:
Drug: Adebrelimab, Apatinib, Gemcitabine, cisplatin

Trial contacts and locations

1

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Central trial contact

Changzhen shang; Yajin Chen

Data sourced from clinicaltrials.gov

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