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Trial Title:
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer
NCT ID:
NCT05820906
Condition:
Advanced Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
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:
Cadonilimab+Regorafenib+GC
Description:
Cadonilimab:10mg/kg, iv,q3w,D1 Regorafenib: 80mg, po, orally once daily Gemcitabine:1000
mg/m2, iv, Q3W，D1,D8 Cisplatin:25 mg/m2, iv, Q3W, D1,D8
Arm group label:
Cadonilimab+rego+Gem/Cis
Summary:
To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and
Gem-Cis chemotherapy in advanced biliary tract Cancer
Criteria for eligibility:
Criteria:
Main Inclusion Criteria:
1. subjects with a histopathological or cytologically diagnosis of BTC
2. The participants must be required to sign an informed consent
3. At least one measurable lesion (RECIST 1.1)
4. No previous systematic treatment for BTC
5. Child-Pugh Score, Class A
6. ECOG performance status 0 or 1
7. Adequate organ function
8. Life expectancy of at least 3 months
Exclusion Criteria:
1. Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma
2. Known history of serious allergy to any monoclonal antibody
3. Known central nervous system metastases and/or leptomeningeal disease prior to
treatment
4. Portal hypertension with esophageal or gastric varices within 6 months prior to
initiation of treatment
5. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
6. Any active malignancy prior to the start of treatment
7. Active or history of autoimmune disease
8. Other acute or chronic conditions, psychiatric disorders, or laboratory
abnormalities that may increase the risk of study participation
9. Pregnant or lactating women
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Cancer Hospital Airport Hospital
Address:
City:
Tianjin
Zip:
300308
Country:
China
Status:
Recruiting
Contact:
Last name:
Huikai Li, MD
Phone:
18622228639
Email:
tjchlhk@126.com
Contact backup:
Last name:
Yayue Liu, Doctor
Phone:
18822002320
Start date:
September 1, 2023
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05820906
