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

NCT ID: NCT05781958

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2024-12-01

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.

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cadonilimab+Gem/Cis

Group Type: EXPERIMENTAL

Cadonilimab+Gem/Cis

Intervention Type: DRUG

Cadonilimab (500mg, iv, Q3W, Day1) with gemcitabine(1000mg/m\^2, iv, Q3W, Day1and Day8) plus cisplatin(25mg/m\^2, iv, Q3W, Day1and Day8) up to 8 cycles followed by cadonilimab (500mg, iv, Q3W, Day1) plus capecitabine（1000 mg/m\^2 orally according to Body Surface Area (BSA)，BID，Q3W，on Days 1-14）as maintenance therapy until disease progression or other discontinuation criteria, up to 24months.

Interventions

Cadonilimab+Gem/Cis

Cadonilimab (500mg, iv, Q3W, Day1) with gemcitabine(1000mg/m\^2, iv, Q3W, Day1and Day8) plus cisplatin(25mg/m\^2, iv, Q3W, Day1and Day8) up to 8 cycles followed by cadonilimab (500mg, iv, Q3W, Day1) plus capecitabine（1000 mg/m\^2 orally according to Body Surface Area (BSA)，BID，Q3W，on Days 1-14）as maintenance therapy until disease progression or other discontinuation criteria, up to 24months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically diagnosed intrahepatic cholangiocarcinoma (ICC)

2. At least 1 measurable lesion (according to RECIST1.1)

3. Have not previously received any systemic treatment

4. Age 18-75 years old, both male and female

5. ECOG performance status score (PS score) 0-2 point

6. Adequate medullary hematopoiesis function: Neutrophils≥1.5*10^9/L; platelets≥100*10^9/L

7. Adequate renal function: creatinine clearance > 60ml/min

8. Adequate hepatic function: Bilirubin ≤ 1.5 times the upper limit of normal

9. No cardiac insufficiency or chest pain (medically uncontrollable); no myocardial infarction in the 12 months prior to study initiation

10. Expectation survival time over 3 months

11. The patient must sign an informed consent form

Exclusion Criteria

1. History of another primary malignancy

2. Brain metastases or spinal cord compression

3. Uncontrolled intercurrent illness

4. Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc)

5. Have received allogeneic organ transplantation

6. 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

7. History of active primary immunodeficiency

8. Pregnant or lactating women

9. Severe or uncontrolled infections

10. Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy;

11. Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;

12. Patients are unsuitable for the enrollment according to investigator's judgement.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shen Feng

OTHER

Sponsor Role: lead

Responsible Party

Shen Feng

Professor and Chief Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBHKY2022-H039-P001

Identifier Type: -

Identifier Source: org_study_id