Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 2
Started
2024-03-01
Last updated
2024-04-23
Condition(s) studied
Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence
Investigational drug(s) / intervention(s)
Adebrelimab, Apatinib, Gemcitabine, cisplatin
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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
1-year EFS rate — Up to approximately 3 years 1-year event-free survival rate
Trial sites (1)
Facility
City
Region
Status
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou
China/Guangdong
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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