Clinical trial · Interventional
A Phase 1b Study of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
An Open-Label, Multiple-Dose Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
NCT07713290CI-TRIAL-00118528active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Unresectable Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GKL-006 Injection | Drug | — | UNRESOLVED |
| Transarterial chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GKL-006 Injection Plus TACE
- description
- Participants will receive GKL-006 Injection in combination with TACE according to the study protocol.
- interventionNames
- Drug: GKL-006 Injection
- Procedure: Transarterial chemoembolization (TACE)
Primary outcomes (1)
- measure
- Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks
- timeFrame
- From the start of study treatment through 14 days after the fourth treatment; treatment-related adverse events will continue to be assessed according to the study protocol.
- description
- Treatment-related adverse events and laboratory abnormalities will be assessed and graded according to NCI CTCAE v5.0. Safety and tolerability risks include study treatment-related adverse events or laboratory abnormalities occurring.
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily participates in the study and provides written informed consent. * Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma. * Has CNLC stage II to IIIa disease. * Has not received transarterial chemoembolization within 6 months before screening. * Has at least one measurable lesion according to mRECIST. * Child-Pugh class A or B. * ECOG performance status of 0 - 2. * Has not received radiotherapy, chemotherapy, targeted therapy, or immunosuppressive therapy within 4 weeks before screening. Exclusion Criteria: * Has a known allergy to the investigational product or related components, including human serum albumin. * Has another incurable malignancy within 5 years before screening or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ, or breast cancer without recurrence for more than 3 years after radical surgery. * Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma. * Has major vascular invasion on imaging. * 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 within 2 weeks before enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.