Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer

Phase 2

Recruiting

• Conditions: Advanced Biliary Tract Cancer
• Interventions: Drug: Cadonilimab+Regorafenib+GC

• Registration Number: NCT05820906
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-20
• Study Start: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cadonilimab+rego+Gem/Cis	Cadonilimab+Regorafenib+GC	-

Primary Outcome Measures

Name	Time	Method
Overall response rate ( ORR) per RECIST 1.1	Up to 1 year	Defined as proportion of patients who have a best response of CR or PR

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR) per RECIST 1.1	Up to 1 year	Defined as proportion of patients who have CR or PR or SD
Progress Free Survival (PFS)	Up to two years	Defined as the time from enrollment to disease progression or death (whichever occurs first)
Overall survival (OS)	Up to two years	Defined as the time from enrollment to death from any cause
Adverse Events (AEs)	Up to two years	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

Trial Locations

Locations (1)

Tianjin Cancer Hospital Airport Hospital; 🇨🇳 Tianjin, Tianjin, China