A Phase 2 interventional study of GKL-006 Injection and TACE in Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Cancer, sponsored by Beijing Gene Key Life Technology Co., Ltd. Recruiting at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Beijing Gene Key Life Technology Co., Ltd · Phase 2, Interventional, and Treatment
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Among 1,309 studies in Carcinoma, Hepatocellular with a site in China — 485 open to participants now, 557 under way, 70 of them phase 3. Carcinoma, Hepatocellular · China.
Among the 1,309 studies in Carcinoma, Hepatocellular with a site in China, this one is the 646th largest by planned enrollment of the 1,033 interventional ones that give a count, is one of 122 that started in 2025, is one of 330 in phase 2, reaches primary completion later than 408 of the 556 other live ones, and was the 1,162nd registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →485 of the 1,309 studies in Carcinoma, Hepatocellular with a site in China are open now. Recruiting first, the newest first:
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18–75
Anhui Provincial Hospital · Sites in China
Ages 18–75
Shanghai Zhongshan Hospital · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,309 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 227 · Phase 2 453 · Phase 3 203 · Phase 4 38
First in 1983; this study’s year is marked. 122 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is below the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 78 across the 1,033 interventional studies, 300 across the 275 observational. Of the 327 that completed or were terminated, 49 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
235 of 1,309 have an industry lead sponsor. The 10 most frequent:
Beijing Gene Key Life Technology Co., Ltd is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Beijing Gene Key Life Technology Co., Ltd has 3 studies filed under Carcinoma, Hepatocellular — fewer than ten, so there is no comparison to draw.
132 of the studies in Carcinoma, Hepatocellular with a site in China that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03368651Phase 3Sun Yat-sen UniversityThe Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial. | 2026-11-30 |
| NCT04344158Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC) | 2026-12 |
| NCT05062837Phase 3Guangxi Medical UniversityHepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC | 2026-12-30 |
| NCT03859128Phase 3Shanghai Junshi Bioscience Co., Ltd.Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection | 2026-12-31 |
| NCT04523493Phase 3Shanghai Junshi Bioscience Co., Ltd.Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC | 2026-12-31 |
Add all 132 to your calendar (.ics) → With an account.
Among the 1,309 studies in Carcinoma, Hepatocellular with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive GKL-006 Injection in combination with TACE according to the study protocol.
Drug: GKL-006 Injection · Procedure: TACE
Participants will receive transarterial chemoembolization (TACE) alone according to the study protocol.
Procedure: TACE
An iNKT cell therapy
Also known as: GKL-006, iNKT cells
A standard locoregional therapy for hepatocellular carcinoma
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 months
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 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 18 months
Time to Progression (TTP)
The time from randomization to the first documented disease progression according to mRECIST.
Time frame: Up to approximately 18 months
Change From Baseline in EORTC QLQ-C30 Score
It will be assessed using the EORTC QLQ-C30 questionnaire.
Time frame: Up to approximately 18 months
Overall Survival (OS)
The time from randomization to death from any cause.
Time frame: Up to approximately 18 months
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events.
Time frame: Up to approximately 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Sep 2027, 22 months after the start.
Of 80 industry-sponsored phase 2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's planned 22 months is below that.
Counting every sponsor, half of 428 studies reached it within 43 months; a quarter within 30 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: GKL-006
Beijing Gene Key Life Technology Co., Ltd →