Hepatocellular Carcinoma (HCC), Unresectable Hepatocellular Cancer
Conditions
Keywords
Hepatocellular carcinoma, iNKT, GKL-006, Immunotherapy, Cell therapy
Brief summary
This is a multicenter, randomized, open-label, controlled Phase 2 study in patients with unresectable hepatocellular carcinoma (uHCC). The purpose of this study is to compare the efficacy and safety of GKL-006 Injection in combination with transarterial chemoembolization (TACE) versus TACE alone.
Detailed description
This Phase 2 study is designed to evaluate a treatment strategy that combines noval immune cell therapy GKL-006 Injection with standard care as TACE in patients with uHCC. Eligible participants will be enrolled at multiple study centers and randomly assigned to receive either GKL-006 Injection in combination with TACE or TACE alone. TACE will be performed in accordance with the study protocol and institutional practice. Participants in the combination group will receive GKL-006 Injection in addition to TACE as specified in the protocol. During the study, participants will undergo scheduled clinical evaluations, laboratory tests, imaging assessments, and safety monitoring. Tumor status will be assessed by investigators and Independent Review Committee (IRC). Safety information, including adverse events, laboratory abnormalities, and clinically significant findings, will be collected throughout treatment and follow-up. The study is intended to characterize the clinical activity and tolerability of the combination regimen compared with TACE alone and to provide supportive evidence for further development of GKL-006 Injection in uHCC.
Interventions
An iNKT cell therapy
PROCEDURETACE
A standard locoregional therapy for hepatocellular carcinoma
Sponsors
Beijing Gene Key Life Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Voluntarily participates in the study and provides written informed consent. * Male or female, age ≥ 18 and ≤ 80 years old * Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma. * Has CNLC stage II to IIIa disease. * Has at least one measurable lesion according to mRECIST. * Child-Pugh class A or B. * ECOG performance status of 0 - 2. * Adequate hematologic and organ function. Main
Exclusion criteria
* Has a known allergy to the investigational product or related components, including human serum albumin and IL-2. * Has another incurable malignancy within 5 years before screening or concurrently. * Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma. * Has received therapy aim to target lesion(s) within 12 weeks before screening. * Has hepatic encephalopathy within 4 weeks before screening. * Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage. * Has other active disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) Assessed by Independent Review Committee Based on mRECIST | Up to approximately 18 months | Progression-free survival is defined as the time from randomization to the first documented disease progression assessed by the independent review committee (IRC) according to mRECIST, or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 18 months | The rate of participants with a best overall response of complete response (CR) or partial response (PR) according to mRECIST. |
| Duration of Response (DOR) | Up to approximately 18 months | Duration of response is defined as the time from the first documented objective response of CR or PR according to mRECIST to disease progression or death from any cause, whichever occurs first. |
| Disease Control Rate (DCR) | Up to approximately 18 months | The rate of participants with a best overall response of CR, PR, or stable disease (SD) according to mRECIST. |
| Progression-Free Survival (PFS) Assessed by Investigator Based on mRECIST | Up to approximately 18 months | Progression-free survival is defined as the time from randomization to the first documented disease progression assessed by the investigator according to mRECIST, or death from any cause, whichever occurs first. |
| Change From Baseline in EORTC QLQ-C30 Score | Up to approximately 18 months | It will be assessed using the EORTC QLQ-C30 questionnaire. |
| Overall Survival (OS) | Up to approximately 18 months | The time from randomization to death from any cause. |
| Incidence and Severity of Adverse Events | Up to approximately 18 months | Safety will be assessed by the incidence and severity of adverse events. |
| Time to Progression (TTP) | Up to approximately 18 months | The time from randomization to the first documented disease progression according to mRECIST. |
Countries
China
Contacts
CONTACTZhongda Hospital
PRINCIPAL_INVESTIGATORGaojun Teng, MD
Zhongda Hospital, South University
Outcome results
None listed