Gene Enlightenment Launches Phase II Clinical Trial of GKL-006 Injection for Hepatocellular Carcinoma

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Beijing Gene Key Life Technology Co., Ltd.'s GKL-006 Injection combined with Transarterial Chemoembolization (TACE) versus TACE alone for the treatment of unresectable hepatocellular carcinoma has initiated a multi-center, randomized, open-label, controlled Phase II clinical trial. The clinical trial registration number is CTR20253777, with the initial information disclosure date on September 28, 2025.

The drug formulation is an injection, with a specification of 100ml. The dosage is administered via intravenous infusion, one bag each time, multiple doses, determined by the actual number of infusions for the subject. The purpose of this trial is to evaluate the efficacy of GKL-006 injection combined with TACE treatment compared to TACE treatment alone in the treatment of unresectable hepatocellular carcinoma.

GKL - 006 Injection is a biologic product indicated for liver cancer. Liver cancer is a malignant tumor that occurs in the liver, with few symptoms in the early stages, but may present with liver area pain, abdominal distension, fatigue, etc., in the middle to late stages. Diagnosis relies on imaging examinations such as ultrasound, CT, MRI, and detection of tumor markers like alpha-fetoprotein.

The primary endpoint of this trial includes evaluating the efficacy of GKL-006 injection combined with TACE treatment compared to TACE treatment alone in unresectable hepatocellular carcinoma; secondary endpoints include evaluating the safety of GKL-006 injection combined with TACE treatment compared to TACE treatment alone in unresectable hepatocellular carcinoma.

Currently, the experiment status is ongoing (not yet recruiting), with a target enrollment of 48 participants.

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Editor: Xiaolang Express