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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Biliary Tract Cancer
• Intervention / Treatment: Drug: Cadonilimab+Regorafenib+GC

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300308
      • Recruiting
      • Tianjin Cancer Hospital Airport Hospital
      • Contact: Huikai Li, MD; Phone Number: 18622228639; Email: tjchlhk@126.com
      • Contact: Yayue Liu, Doctor; Phone Number: 18822002320

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cadonilimab+rego+Gem/Cis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: AK104-IIT-C-N1-0057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No