Back to resultsCadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer
Primary Purpose
Advanced Biliary Tract Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cadonilimab+Regorafenib+GC
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Biliary Tract Cancer
Eligibility Criteria
Main Inclusion Criteria: subjects with a histopathological or cytologically diagnosis of BTC The participants must be required to sign an informed consent At least one measurable lesion (RECIST 1.1) No previous systematic treatment for BTC Child-Pugh Score, Class A ECOG performance status 0 or 1 Adequate organ function Life expectancy of at least 3 months Exclusion Criteria: Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma Known history of serious allergy to any monoclonal antibody Known central nervous system metastases and/or leptomeningeal disease prior to treatment Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment Any active malignancy prior to the start of treatment Active or history of autoimmune disease Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation Pregnant or lactating women
Sites / Locations
- Tianjin Cancer Hospital Airport Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cadonilimab+rego+Gem/Cis
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate ( ORR) per RECIST 1.1
Defined as proportion of patients who have a best response of CR or PR
Secondary Outcome Measures
Overall survival (OS)
Defined as the time from enrollment to death from any cause
Progress Free Survival (PFS)
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Adverse Events (AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Disease control rate (DCR) per RECIST 1.1
Defined as proportion of patients who have CR or PR or SD
Full Information
NCT ID
NCT05820906
First Posted
April 7, 2023
Last Updated
April 7, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05820906
Brief Title
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer
Official Title
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Biliary Tract Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cadonilimab+rego+Gem/Cis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cadonilimab+Regorafenib+GC
Intervention 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
Primary Outcome Measure Information:
Title
Overall response rate ( ORR) per RECIST 1.1
Description
Defined as proportion of patients who have a best response of CR or PR
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Defined as the time from enrollment to death from any cause
Time Frame
Up to two years
Title
Progress Free Survival (PFS)
Description
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Time Frame
Up to two years
Title
Adverse Events (AEs)
Description
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Time Frame
Up to two years
Title
Disease control rate (DCR) per RECIST 1.1
Description
Defined as proportion of patients who have CR or PR or SD
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
subjects with a histopathological or cytologically diagnosis of BTC
The participants must be required to sign an informed consent
At least one measurable lesion (RECIST 1.1)
No previous systematic treatment for BTC
Child-Pugh Score, Class A
ECOG performance status 0 or 1
Adequate organ function
Life expectancy of at least 3 months
Exclusion Criteria:
Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma
Known history of serious allergy to any monoclonal antibody
Known central nervous system metastases and/or leptomeningeal disease prior to treatment
Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
Any active malignancy prior to the start of treatment
Active or history of autoimmune disease
Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
Pregnant or lactating women
Facility Information:
Facility Name
Tianjin Cancer Hospital Airport Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300308
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer
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