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NCT Number: NCT06280508

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

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.

Recruiting

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Key information

Conditions

Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adebrelimab, Apatinib, Gemcitabine, cisplatin

Drug

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 outcomes

  1. 1-year EFS rate

    Time frame: Up to approximately 3 years

    1-year event-free survival rate

Secondary outcomes

  1. R0 Resection rate

    Time frame: Up to approximately 3 years

    R0 Resection rate

  2. EFS

    Time frame: Up to approximately 3 years

    Event-free survival

  3. RFS

    Time frame: Up to approximately 3 years

    Recurrence-free survival

  4. OS

    Time frame: Up to approximately 3 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Changzhen shang

CONTACT

[email protected]

13711279678

Yajin Chen

CONTACT

[email protected]

13719006202

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.