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Recruiting NCT06280508

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

Phase II Interventional Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adebrelimab, Apatinib, Gemcitabine, cisplatin.
Who it may be relevant to
Registry conditions: Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Adebrelimab, 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

Primary outcome measures

  • 1-year EFS rate [Time frame: Up to approximately 3 years]
Secondary outcome measures (4)
  • R0 Resection rate [Time frame: Up to approximately 3 years]
  • EFS [Time frame: Up to approximately 3 years]
  • RFS [Time frame: Up to approximately 3 years]
  • OS [Time frame: Up to approximately 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT06280508 · SYSKY-2024-082-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗