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

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05820906
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Overall survival (OS) [Up to two years]

    Defined as the time from enrollment to death from any cause

  2. Progress Free Survival (PFS) [Up to two years]

    Defined as the time from enrollment to disease progression or death (whichever occurs first)

  3. 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

  4. Disease control rate (DCR) per RECIST 1.1 [Up to 1 year]

    Defined as proportion of patients who have CR or PR or SD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Cancer Hospital Airport Hospital Tianjin Tianjin China 300308

Sponsors and Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HuiKai Li, Professor and Chief Surgeon, Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT05820906
Other Study ID Numbers:
  • AK104-IIT-C-N-0060
First Posted:
Apr 20, 2023
Last Update Posted:
Apr 20, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Biliary Tract Neoplasms

Study Results

No Results Posted as of Apr 20, 2023