Condition: Advanced or Unresectable Hepatocellular Carcinoma (HCC) · Sponsor: Huahui Health
This is a randomized, open-label, multicenter Phase Ib/II registration trial designed to evaluate the efficacy and safety of HH-009 in patients with FGF19-positive hepatocellular carcinoma (HCC). The study will also assess pharmacokinetics, pharmacodynamics, immunogenicity, and exploratory biomarkers. Approximately 30 patients with FGF19-positive advanced HCC will be enrolled. Eligible participants will be randomized 1:1 to receive HH-009 at either 20 mg/kg or 30 mg/kg Q3W as monotherapy. Treatment will continue until disease progression, unacceptable toxicity, initiation of new anticancer therapy, study withdrawal, completion of two years of treatment, loss to follow-up, death, or other protocol-specified reasons, whichever occurs first.
This description comes directly from the study's public registry record.
Xiyu Zhang PM · 18701650516 · zhangxiyu@hhhbio.com
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital of Bengbu Medical University | Bengbu, Anhui, China | Not Yet Recruiting |
| Anhui Provincial Hospital | Hefei, Anhui, China | Not Yet Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Not Yet Recruiting |
| Capital Medical University Affiliated Beijing Ditan Hospital | Beijing, Beijing Municipality, China | Recruiting |
| The Fifth Medical Center of the PLA General Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou, Fujian, China | Not Yet Recruiting |
| NanFang Hospital of Southern Medical University | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Affiliated Tumor Hospital of Guangxi Medical University | Nanning, Guangxi, China | Not Yet Recruiting |
| Guangxi Zhuang Autonomous Region People's Hospital | Nanning, Guangxi, China | Not Yet Recruiting |
| Harbin Medical University Affiliated Cancer Hospital | Harbin, Heilongjiang, China | Not Yet Recruiting |
| Henan Provincial Cancer Hospital | Zhengzhou, Henan, China | Not Yet Recruiting |
| The First Affiliated Hospital of Henan Medical University | Zhengzhou, Henan, China | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07547553