Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）.

NCT06375486 | Recruiting Phase 2

• 1 other identifier: AK112-IIT-TianjinCIH-LHK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma. All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first.

Conditions

Hepatocellular Carcinoma Non-resectable; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Defined as proportion of patients who have a best response of CR or PR

  up to 1 year

Secondary Outcomes (3)

• Progress Free Survival （PFS）

  up to 2 years

• Overall survival (OS)

  up to 2 years

• Adverse Events（AEs）

  up to 3 years

Study Arms (1)

AK112 arm

EXPERIMENTAL

The patients will receive AK112（PD-1/VEGF bispecific antibody）plus HAIC

Drug: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）

Interventions

Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） DRUG

All enrolled subjects will receive Ivonescimab（AK112，a PD-1/VEGF bispecific antibody，20mg/kg Q3W) in combination with HAIC (utilizing the FOLFOX chemotherapy regimen)

Also known as: HAIC

AK112 arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign a written informed consent form.
• Age at enrollment is ≥ 18 years and ≤ 75 years, both males and females are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Expected survival ≥ 3 months.
• Confirmed histologically/cytologically or cirrhotic patients meeting the Barcelona Clinic Liver Cancer (BCLC) stage B or C criteria for hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria.
• Not suitable for curative treatment (surgery or ablation) and have not previously received systemic anti-tumor therapy for unresectable HCC.
• Liver function classified as Child-Pugh class A.
• Sufficient organ function.

You may not qualify if:

• Components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc., confirmed histologically/cytologically.
• Apart from HCC, subjects have had other malignant tumors within 5 years prior to enrollment. Subjects who have been cured of other malignant tumors through local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. If diagnosed with liver cancer or other malignant tumors more than 5 years before dosing, pathological histology or cytology diagnosis of recurrent metastatic lesions is required.
• Poor compliance, unable to cooperate and describe treatment responses.
• History of past or current central nervous system (CNS) metastasis or leptomeningeal metastasis.
• Presence of extrahepatic metastasis.
• History of hepatic encephalopathy or liver transplantation.
• Clinical symptoms or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
• History of or current non-infectious pneumonia or interstitial lung disease requiring systemic corticosteroid therapy.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Huikai Li, MD

CONTACT

18622228639; tjchlhk@126.com

Yang Liu, doctor

CONTACT

17694950696; tjchlhk@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 19, 2024
• Study Start: March 14, 2024
• Primary Completion: March 14, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (1)