GKL-006 plus TACE vs TACE alone for unresectable liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized Phase 2 study comparing GKL-006 Injection plus transarterial chemoembolization (TACE) to TACE alone in adults with unresectable hepatocellular carcinoma. Participants are randomly assigned to receive the combination therapy or standard TACE, and they will undergo regular clinical assessments, lab tests, imaging, and safety monitoring. Tumor response will be evaluated by investigators and an independent review committee. The study aims to characterize the activity and tolerability of the combination regimen to support further development of GKL-006 in uHCC.

Why it matters

Who can join: the full rules

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.

Where it's running

• 302 Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Zhongda Hospital
  Nanjing, Jiangsu, China Recruiting
• Nanjing Second Hospital
  Nanjing, Jiangsu, China Recruiting
• Jiangxi Cancer Hospital
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Principal investigator: Gaojun Teng, MD — Zhongda Hospital, South University
• Study coordinator: Zhongda Hospital
• Email: gjteng@seu.edu.cn
• Phone: +86-25-83272121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.