Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer
NCT ID: NCT05820906
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2023-09-01
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cadonilimab+rego+Gem/Cis
Cadonilimab+Regorafenib+GC
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
Interventions
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Cadonilimab+Regorafenib+GC
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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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HuiKai Li
Professor and Chief Surgeon
Locations
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Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Countries
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Facility Contacts
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Huikai Li, MD
Role: primary
Yayue Liu, Doctor
Role: backup
Other Identifiers
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AK104-IIT-C-N1-0057
Identifier Type: -
Identifier Source: org_study_id