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
Qualifiers
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
Treatments tested in this trial
- GKL-006 Injection
- TACE
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov