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

Advanced Biliary Tract Cancer Clinical Trial

Official title:

Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820906
• Other study ID #: AK104-IIT-C-N1-0057
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Tianjin Cancer Hospital Airport Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate ( ORR) per RECIST 1.1	Defined as proportion of patients who have a best response of CR or PR	Up to 1 year
Secondary	Overall survival (OS)	Defined as the time from enrollment to death from any cause	Up to two years
Secondary	Progress Free Survival (PFS)	Defined as the time from enrollment to disease progression or death (whichever occurs first)	Up to two years
Secondary	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	Up to two years
Secondary	Disease control rate (DCR) per RECIST 1.1	Defined as proportion of patients who have CR or PR or SD	Up to 1 year