GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Gene Key Life Technology Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GKL-006 Injection
DrugAn iNKT cell therapy
TACE
Procedure/SurgeryA standard locoregional therapy for hepatocellular carcinoma
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: GKL-006 injection in combination with TACEExperimental treatment 2 interventions
Group B: TACE aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS) Assessed by Independent Review Committee Based on mRECIST
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.
Time frame
Up to approximately 18 monthsSecondary outcomes
1
Progression-Free Survival (PFS) Assessed by Investigator Based on mRECIST
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.
Time frame
Up to approximately 18 months2
Objective Response Rate (ORR)
The rate of participants with a best overall response of complete response (CR) or partial response (PR) according to mRECIST.
Time frame
Up to approximately 18 months3
Duration of Response (DOR)
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.
Time frame
Up to approximately 18 months4
Disease Control Rate (DCR)
The rate of participants with a best overall response of CR, PR, or stable disease (SD) according to mRECIST.
Time frame
Up to approximately 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov