Actively Recruiting
ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression
Led by Abbisko Therapeutics Co, Ltd · Updated on 2026-01-08
141
Participants Needed
51
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign the informed consent form and be willing to comply with study visits and procedures.
- Male or female patients aged 18 years or older at the time of consent.
- Advanced or unresectable hepatocellular carcinoma confirmed by pathology or clinical criteria.
- Must have received at least one prior PD-(L)1 inhibitor and one multi-tyrosine kinase inhibitor approved for HCC treatment.
- BCLC stage B (not eligible for or progressed after local/radical therapy) or stage C.
- Child-Pugh class A liver function.
- Positive for FGF19 overexpression.
- At least one measurable tumor lesion according to RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate blood pressure control at screening.
- Adequate organ and bone marrow function.
- Patients of childbearing potential must use reliable contraception from 2 weeks before randomization until 1 month after last dose.
You will not qualify if you...
- Known allergies or hypersensitivity to ABSK-011, placebo, or any of their components.
- Prior treatment with selective FGFR4 inhibitors.
- Diagnosis of fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma.
- Previous anti-tumor therapy within 4 weeks before randomization.
- Major surgery within 4 weeks before randomization or surgical wound issues within 2 weeks before randomization.
- History of other primary cancers within 5 years, excluding HCC.
- Liver tumors involving 50% or more of the whole liver.
- Unresolved toxicities from prior cancer treatments above Grade 1.
- Tumor involvement of main portal vein, inferior/superior vena cava, superior mesenteric vein, or heart.
- Impaired heart function or significant heart disease.
- Co-infection with hepatitis B and C viruses.
- Known AIDS-related disease or positive HIV test.
- Active or recent gastrointestinal bleeding within 6 months.
- Uncontrolled pleural or pericardial effusion requiring intervention within 2 weeks before randomization.
- Prior or current hepatic encephalopathy.
- Presence of meningeal or central nervous system metastases.
- Previous organ transplant and use of anti-rejection drugs.
- Factors significantly affecting oral drug absorption.
- Use of certain drug transport or enzyme inhibitors or inducers within 2 weeks before randomization.
- Serious infections requiring systemic treatment within 2 weeks before randomization.
- Allergy or contraindication to contrast agents for CT or MRI.
- Other serious health conditions that may affect safety, consent, compliance, or study results.
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Trial Site Locations
Total: 51 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
3
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Actively Recruiting
4
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
5
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
6
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
7
Chongqing university cancer hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
8
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
9
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
10
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
11
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
12
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Actively Recruiting
13
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Actively Recruiting
14
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
15
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Actively Recruiting
16
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
17
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Actively Recruiting
18
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
19
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
20
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
21
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
22
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
23
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
24
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
25
General Hospital of Easten Theater Command
Nanjing, Jiangsu, China
Not Yet Recruiting
26
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
Actively Recruiting
27
The First Affiliated Hospital with NanJing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
28
Nantong Tumor Hospital
Nantong, Jiangsu, China
Actively Recruiting
29
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
30
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Actively Recruiting
31
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
32
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
33
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
34
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
35
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Actively Recruiting
36
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
37
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Actively Recruiting
38
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
39
Affiliated Hospital ofJining Medical University
Jining, Shandong, China
Actively Recruiting
40
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
41
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
42
Renji Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
43
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
44
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Actively Recruiting
45
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Actively Recruiting
46
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Actively Recruiting
47
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
48
Mianyang Central Hospital
Mianyang, Sichuan, China
Actively Recruiting
49
TianJin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
50
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
51
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
X
Xiaoping Chen
CONTACT
Q
Qi Cheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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