ABSK-011+BSC: ABSK-011 capsules will be provided and should be taken twice daily, with an interval of approximately 12 hours. The investigational product should be taken with food, with approximately 150 mL of water.
Placebo+BSC: Placebo capsules will be provided and should be taken twice daily, with an interval of approximately 12 hours. The investigational product should be taken with food, with approximately 150 mL of water.
This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio. Patients will receive assigned study treatment, every 28-day treatment cycle within 1 day of randomization until disease progression, intolerable toxicity, start of new anti-tumor therapy, death, patient refuse to continue treatment, loss to follow-up, or other reasons leading to treatment discontinuation. Immediate BICR review is required for patients with radiographic disease progression as assessed by the investigator. If disease progression is assessed by BICR, the investigator is allowed to unblind after disease progression according to the protocol-specified procedures. After unblinding, patients in the experimental arm, study drug should be discontinued. Patients in the control arm may be transferred to receive ABSK-011 plus BSC after assessment.
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Provincial Cancer Hospital | Hefei | Anhui | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Recruiting |
| The First Affiliated Hospital of USTC | Hefei | Anhui | Recruiting |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Recruiting |
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | Recruiting |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | Recruiting |
| Chongqing university cancer hospital | Chongqing | Chongqing Municipality | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | Recruiting |
| Fujian Cancer Hospital | Fuzhou | Fujian | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| The Second Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | Recruiting |
| Liuzhou People's Hospital | Liuzhou | Guangxi | Recruiting |
| Guangxi Medical University Cancer Hospital | Nanning | Guangxi | Recruiting |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | Recruiting |
| Affiliated Cancer Hospital of Harbin Medical University | Harbin | Heilongjiang | Recruiting |
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Hubei Cancer Hospital | Wuhan | Hubei | Recruiting |
| Tongji Hospital | Wuhan | Hubei | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Recruiting |
| General Hospital of Easten Theater Command | Nanjing | Jiangsu | Not Yet Recruiting |
| Nanjing Tianyinshan Hospital | Nanjing | Jiangsu | Recruiting |
| The First Affiliated Hospital with NanJing Medical University | Nanjing | Jiangsu | Recruiting |
| Nantong Tumor Hospital | Nantong | Jiangsu | Recruiting |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | Recruiting |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi | Recruiting |
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | Recruiting |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| Jilin Cancer Hospital | Changchun | Jilin | Recruiting |
| The First Hospital of Jilin University | Changchun | Jilin | Recruiting |
| Liaoning Cancer Hospital | Shenyang | Liaoning | Recruiting |
| The First Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
| Affiliated Hospital ofJining Medical University | Jining | Shandong | Recruiting |
| Eastern hepatobilliary surgery hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
+ 11 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07327034 on ClinicalTrials.gov ↗ ← All trials in China