Hepatocellular Carcinoma (HCC)Phase 2NCT07209813
GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing GKL-006 Injection and TACE in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Cancer, run by Beijing Gene Key Life Technology Co., Ltd at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Unresectable Hepatocellular Cancer
- What is being tested?
- GKL-006 Injection and TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesChina
- Study dates
- 14 Nov 2025to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
302 Hospital
Beijing, Beijing Municipality, 100039
Hepatobiliary Surgery, Department of Hepatology, +86-1066933114, zhuzy302@163.com
Zhenyu Zhu, MD
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Hepatobiliary Surgery, +86-731-85295999, liuweixy@csu.edu.cn
Wei Liu, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Department of Interventional Therapy, +86-571-88122222, zenghuiray@aliyun.com
Hui Zeng, MD
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Interventional Department, +86-13576935622, 41906001@qq.com
Xiaoyong Wei, MD
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Interventional Treatment Center, +86-25-83272121, gjteng@seu.edu.cn
Gaojun Teng, MD
- Recruiting
Nanjing Second Hospital
Nanjing, Jiangsu
Tumor and Vascular Disease Interventional Center, +86-25-58006129, med@chinagkl.com
Jie Qiu, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Biological Cell Therapy Center, +86-371-67966266, yizhang001@163.com
Yi Zhang, MD
About this study
Official title: A Multicenter, Randomized, Open-Label, Controlled Phase 2 Study of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
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.
Read the 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.
- Being tested
- GKL-006 Injection, TACE
- Keywords
- Hepatocellular carcinoma, iNKT, GKL-006, Immunotherapy, Cell therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKL-006 InjectionDrug
Also called GKL-006, iNKT cells
An iNKT cell therapy
TACEProcedure or surgery
A standard locoregional therapy for hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| GKL-006 injection in combination with TACE | Experimental | Participants will receive GKL-006 Injection in combination with TACE according to the study protocol. Receives: Drug: GKL-006 Injection; Procedure: TACE |
| TACE alone | Active comparator | Participants will receive transarterial chemoembolization (TACE) alone according to the study protocol. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 18 months
Secondary outcomes (8)
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.
Measured: Up to approximately 18 months
Objective Response Rate (ORR)
The rate of participants with a best overall response of complete response (CR) or partial response (PR) according to mRECIST.
Measured: Up to approximately 18 months
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.
Measured: Up to approximately 18 months
Disease Control Rate (DCR)
The rate of participants with a best overall response of CR, PR, or stable disease (SD) according to mRECIST.
Measured: Up to approximately 18 months
Time to Progression (TTP)
The time from randomization to the first documented disease progression according to mRECIST.
Measured: Up to approximately 18 months
Change From Baseline in EORTC QLQ-C30 Score
It will be assessed using the EORTC QLQ-C30 questionnaire.
Measured: Up to approximately 18 months
Overall Survival (OS)
The time from randomization to death from any cause.
Measured: Up to approximately 18 months
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events.
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start14 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaojun Teng, MD, Principal investigator, Zhongda Hospital, South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209813
- Sponsor's protocol ID
- GKL006HCC03
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Controlled Phase 2 Study of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07209813
- Acronym / sponsor ID
- GKL006HCC03
- Keywords
- Hepatocellular carcinoma, iNKT, GKL-006, Immunotherapy, Cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Gene Key Life Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GKL-006 injection in combination with TACE | Experimental | Drug: GKL-006 Injection, Procedure: TACEParticipants will receive GKL-006 Injection in combination with TACE according to the study protocol. |
| TACE alone | Active comparator | Procedure: TACEParticipants will receive transarterial chemoembolization (TACE) alone according to the study protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GKL-006 InjectionAlso: GKL-006, iNKT cellsAn iNKT cell therapy | Drug | GKL-006 injection in combination with TACE |
| TACEA standard locoregional therapy for hepatocellular carcinoma | Procedure or surgery | GKL-006 injection in combination with TACE, TACE alone |
Primary outcome
Progression-Free Survival (PFS) Assessed by Independent Review Committee Based on mRECIST
Time frame: 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.
8 secondary outcomes
Progression-Free Survival (PFS) Assessed by Investigator Based on mRECIST
Time frame: Up to approximately 18 months
Objective Response Rate (ORR)
Time frame: Up to approximately 18 months
Duration of Response (DOR)
Time frame: Up to approximately 18 months
Disease Control Rate (DCR)
Time frame: Up to approximately 18 months
Time to Progression (TTP)
Time frame: Up to approximately 18 months
Change From Baseline in EORTC QLQ-C30 Score
Time frame: Up to approximately 18 months
Overall Survival (OS)
Time frame: Up to approximately 18 months
Incidence and Severity of Adverse Events
Time frame: Up to approximately 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 3
Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
RecruitingPhase 2
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Hepatocellular Carcinoma, HCC
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaojun Teng, MD principal investigator
Zhongda Hospital, South University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GKL-006 Injection and TACE in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Cancer, run by Beijing Gene Key Life Technology Co., Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongda Hospital (+86-25-83272121, gjteng@seu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Assessed by Independent Review Committee Based on mRECIST (time frame: Up to approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.