To hear about similar clinical trials, please enter your email below
Trial Title:
Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
NCT ID:
NCT06280508
Condition:
Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence
Conditions: Official terms:
Cholangiocarcinoma
Biliary Tract Neoplasms
Recurrence
Gemcitabine
Apatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab, Apatinib, Gemcitabine, cisplatin
Description:
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
Arm group label:
treatment arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yajin Chen
Phone:
13719006202
Email:
cyj0509@126.com
Contact backup:
Last name:
Changzhen Shang
Phone:
13711279678
Email:
shangchangzhen@139.com
Start date:
March 1, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06280508
