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

NCT05820906 | Unknown Phase 2

• 1 other identifier: AK104-IIT-C-N1-0057
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival (OS)

  Up to two years

• Progress Free Survival (PFS)

  Up to two years

• Adverse Events (AEs)

  Up to two years

• Disease control rate (DCR) per RECIST 1.1

  Up to 1 year

Study Arms (1)

Cadonilimab+rego+Gem/Cis

EXPERIMENTAL

Drug: Cadonilimab+Regorafenib+GC

Interventions

Cadonilimab+Regorafenib+GC DRUG

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

Cadonilimab+rego+Gem/Cis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Surgeon

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)