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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06280508

Enrollment

Registered

2024-02-28

Start date

2024-03-01

Completion date

2028-03-31

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence

Brief 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.

Interventions

DRUGAdebrelimab, 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
1-year EFS rate	Up to approximately 3 years	1-year event-free survival rate

Secondary

Measure	Time frame	Description
R0 Resection rate	Up to approximately 3 years	R0 Resection rate
EFS	Up to approximately 3 years	Event-free survival
RFS	Up to approximately 3 years	Recurrence-free survival
OS	Up to approximately 3 years	Overall survival

Countries

China

Contacts

Primary ContactYajin Chen

cyj0509@126.com13719006202

Backup ContactChangzhen shang

shangchangzhen@139.com13711279678

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026