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Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC

Primary Purpose

Intrahepatic Cholangiocarcinoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cadonilimab+Gem/Cis
Sponsored by
Shen Feng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring cadonilimab (anti-PD-1/CTLA-4 bispecific antibody)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically diagnosed intrahepatic cholangiocarcinoma (ICC) At least 1 measurable lesion (according to RECIST1.1) Have not previously received any systemic treatment Age 18-75 years old, both male and female ECOG performance status score (PS score) 0-2 point Adequate medullary hematopoiesis function: Neutrophils≥1.5*10^9/L; platelets≥100*10^9/L Adequate renal function: creatinine clearance > 60ml/min Adequate hepatic function: Bilirubin ≤ 1.5 times the upper limit of normal No cardiac insufficiency or chest pain (medically uncontrollable); no myocardial infarction in the 12 months prior to study initiation Expectation survival time over 3 months The patient must sign an informed consent form Exclusion Criteria: History of another primary malignancy Brain metastases or spinal cord compression Uncontrolled intercurrent illness Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc) Have received allogeneic organ transplantation Control of concurrent complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, poorly controlled arrhythmia, active interstitial lung disease ( ILD), severe chronic gastrointestinal disorders associated with diarrhea symptoms, may limit compliance with the psychiatric/social conditions required by the trial, and substantially increase the risk of adverse events or affect the ability of patients to sign written consent forms History of active primary immunodeficiency Pregnant or lactating women Severe or uncontrolled infections Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy; Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results; Patients are unsuitable for the enrollment according to investigator's judgement.

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cadonilimab+Gem/Cis

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate (ORR) per RECIST 1.1
Defined as patients achieving a complete response [CR] or partial response [PR]

Secondary Outcome Measures

Progression free survival (PFS) per RECIST 1.1
Defined as the time from the start of treatment to the date of progressive disease, or death, whichever occurred first.
Desease control rate (DCR) per RECIST 1.1
CR + PR + SD
Overall survival (OS)
Defined as the time from the start of treatment to the date of death from any cause
6mo PFS rate per RECIST 1.1
Progression-free survival (PFS) rate at 6 months
adverse events
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events

Full Information

First Posted
February 20, 2023
Last Updated
March 22, 2023
Sponsor
Shen Feng
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1. Study Identification

Unique Protocol Identification Number
NCT05781958
Brief Title
Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC
Official Title
Cadonilimab Combined With Gemcitabine and Cisplatin as First Line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma: A Single Center, Single Arm, Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shen Feng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
TOPAZ-1 phase III trail demonstrated that the addition of immune checkpoint inhibitor anti-PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS) compared to Gem/Cis alone. Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with gemcitabine and cisplatin as first Line therapy in patients with advanced intrahepatic cholangiocarcinoma. Eligible participants will receive cadonilimab (up to 12 months) plus gemcitabine and cisplatin (for maximum of 6-8 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
Keywords
cadonilimab (anti-PD-1/CTLA-4 bispecific antibody)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cadonilimab+Gem/Cis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cadonilimab+Gem/Cis
Intervention Description
Cadonilimab (500mg, iv, Q3W, Day1)+Gemcitabine (1000mg/m2, iv, Q3W, Day1and Day8)+Cisplatin (25mg/m2, iv, Q3W, Day1and Day8) Cadonilimab: up to 12months Gem/Cis: 6-8cycles
Primary Outcome Measure Information:
Title
Objective response rate (ORR) per RECIST 1.1
Description
Defined as patients achieving a complete response [CR] or partial response [PR]
Time Frame
Up to two years
Secondary Outcome Measure Information:
Title
Progression free survival (PFS) per RECIST 1.1
Description
Defined as the time from the start of treatment to the date of progressive disease, or death, whichever occurred first.
Time Frame
Up to two years
Title
Desease control rate (DCR) per RECIST 1.1
Description
CR + PR + SD
Time Frame
Up to two years
Title
Overall survival (OS)
Description
Defined as the time from the start of treatment to the date of death from any cause
Time Frame
Up to two years
Title
6mo PFS rate per RECIST 1.1
Description
Progression-free survival (PFS) rate at 6 months
Time Frame
at 6 months
Title
adverse events
Description
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events
Time Frame
Up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically diagnosed intrahepatic cholangiocarcinoma (ICC) At least 1 measurable lesion (according to RECIST1.1) Have not previously received any systemic treatment Age 18-75 years old, both male and female ECOG performance status score (PS score) 0-2 point Adequate medullary hematopoiesis function: Neutrophils≥1.5*10^9/L; platelets≥100*10^9/L Adequate renal function: creatinine clearance > 60ml/min Adequate hepatic function: Bilirubin ≤ 1.5 times the upper limit of normal No cardiac insufficiency or chest pain (medically uncontrollable); no myocardial infarction in the 12 months prior to study initiation Expectation survival time over 3 months The patient must sign an informed consent form Exclusion Criteria: History of another primary malignancy Brain metastases or spinal cord compression Uncontrolled intercurrent illness Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc) Have received allogeneic organ transplantation Control of concurrent complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, poorly controlled arrhythmia, active interstitial lung disease ( ILD), severe chronic gastrointestinal disorders associated with diarrhea symptoms, may limit compliance with the psychiatric/social conditions required by the trial, and substantially increase the risk of adverse events or affect the ability of patients to sign written consent forms History of active primary immunodeficiency Pregnant or lactating women Severe or uncontrolled infections Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy; Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results; Patients are unsuitable for the enrollment according to investigator's judgement.
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20043
Country
China

12. IPD Sharing Statement

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Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC

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