NCT07209813RecruitingPhase 2
GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 29 Sept 2025
- Start date
- 14 Nov 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07209813
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 14 Nov 2025 to the primary completion date, 30 Sept 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 302 Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Jiangxi Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Zhongda Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Nanjing Second Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.