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

• Sponsor: Shen Feng (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05781958
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24.2
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: Cadonilimab+Gem/Cis	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 24, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cadonilimab+Gem/Cis	Drug: Cadonilimab+Gem/Cis; 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

Outcome Measures

Primary Outcome Measures

1. Objective response rate (ORR) per RECIST 1.1 [Up to two years]

   Defined as patients achieving a complete response [CR] or partial response [PR]

Secondary Outcome Measures

1. Progression free survival (PFS) per RECIST 1.1 [Up to two years]

   Defined as the time from the start of treatment to the date of progressive disease, or death, whichever occurred first.

2. Desease control rate (DCR) per RECIST 1.1 [Up to two years]

   CR + PR + SD

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

   Defined as the time from the start of treatment to the date of death from any cause

4. 6mo PFS rate per RECIST 1.1 [at 6 months]

   Progression-free survival (PFS) rate at 6 months

5. adverse events [Up to two years]

   Include Treatment emerge adverse events, treatment related adverse events and serious adverse events

Eligibility Criteria

Criteria

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

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≥1.510^9/L; platelets≥10010^9/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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai	China	20043

Sponsors and Collaborators

• Shen Feng

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shen Feng, Professor and Chief Surgeon, Eastern Hepatobiliary Surgery Hospital
• ClinicalTrials.gov Identifier: NCT05781958
• Other Study ID Numbers: EHBHKY2022-H039-P001
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shen Feng, Professor and Chief Surgeon, Eastern Hepatobiliary Surgery Hospital: cadonilimab (anti-PD-1/CTLA-4 bispecific antibody)
• Additional relevant MeSH terms: Cholangiocarcinoma

Study Results

No Results Posted as of Mar 23, 2023