Hepatocellular Carcinoma (HCC)Phase 2NCT07327034
ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression
A Phase 2 study testing ABSK-011+BSC in people with Hepatocellular Carcinoma (HCC), run by Abbisko Therapeutics Co, Ltd at 51 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- ABSK-011+BSC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 51 sitesChina
- Study dates
- 13 Jun 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures as per protocol.
- Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form.
- Patients with advanced or unresectable HCC confirmed histologically/cytologically or clinically according to the American Association for the Study of Liver Diseases (AASLD) criteria (for patients with cirrhosis).
- Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI approved for the treatment of HCC.
- BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C.
- Child-Pugh class A.
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- Positive for FGF19 overexpression.
- At least 1 measurable lesion meeting RECIST v1.1 criteria.
- ECOG performance status 0 or 1.
- Life expectancy ≥ 3 months.
- Adequate control of blood pressure (BP) at screening.
- Adequate organ function and bone marrow function.
- Non-surgically sterilized male or female patients of childbearing potential must agree to use reliable contraception for at least 2 weeks prior to randomization until 1 month after the last dose of study treatment.
Who cannot join
- Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo).
- Previous treatment with selective FGFR4 inhibitors.
- Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma.
- Previous anti-tumor therapy is ≤ 4 weeks from randomization.
- Major surgery within 4 weeks prior to randomization; or any surgical wound infection, dehiscence, or incomplete healing within 2 weeks prior to randomization; Or major surgery is planned during study treatment.
- History of second primary malignancies other than HCC within the first 5 years of screening.
Show all 22Show fewer
- Liver tumors as a percentage of whole liver ≥ 50% as judged by the investigator.
- Toxicities caused by prior chemotherapy, radiotherapy, and other anti-tumor therapies (including immunotherapy) did not recover to ≤ Grade 1 CTCAE v5.0.
- Imaging revealed HCC involving the main portal vein (Vp4), inferior vena cava, superior vena cava, superior mesenteric vein, or heart.
- Impaired cardiac function or clinically important heart disease.
- Patients coinfected with HBV and HCV.
- Known acquired immunodeficiency syndrome (AIDS) -associated disease or tested positive for HIV 1/2 antibodies.
- Active or documented gastrointestinal bleeding within 6 months prior to screening.
- Patients with intractable/uncontrolled pleural or pericardial effusion requiring intervention within 2 weeks prior to randomization and clinically significant ascites.
- Prior or current hepatic encephalopathy (any grade).
- Presence of meningeal or central nervous system (CNS) metastases.
- Previous organ transplant and anti-rejection drug therapy indicated.
- The factors that significantly affect the absorption of oral drugs.
- Receipt of P-gp transporter inhibitors or moderate, strong inhibitors or inducers of CYP3A4 within 2 weeks prior to randomization.
- Any serious acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks prior to randomization.
- Patient who cannot be assessed by contrast-enhanced CT and/or MRI due to allergy to computed tomography (CT) and/or magnetic resonance imaging (MRI) contrast media or other contraindications.
- Any other clinically significant comorbidities may affect the patient's health or safety, affect the signing of informed consent, affect protocol compliance, or interfere with the interpretation of the study results.
Trial locations and contacts
51 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Qi Cheng contact
51 sites in 1 country
China51 sites, 51 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
Gong Li, +86-13366061906, lga02375@btch.edu.cn
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Haitao Zhao, +86-010-69156042, zhaoht@pumch.cn
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin
Maonan Wang, +86-13578684765, ccwmnd@163.com
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Wei Li, 13756661267, jdyylw@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Shanzhi Gu, 13574865998, gushanzhi@hnca.org.cn
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Jia Luo, 13874994359, luojia@hnca.org.cn
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Dan Cao, 18980605963, caodan@wchscu.cn
- Recruiting
Chongqing university cancer hospital
Chongqing, Chongqing Municipality
Dewei Li, 13618317772, lidewei406@sina.com
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Yong Chen, 13272822116, doctorcy007@163.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Hui Zhang, 13905029580, zh2405@hotmail.com
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
Xueming Xu, +86-18870881103, 435101255@qq.com
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Chao Liu, 13682294418, liuchao3@mail.sysu.edu.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Xu, +86-13527656798, xuli@sysucc.org.cn
- Recruiting
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Bihui Li, 18378316283, lbihui0202@163.com
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou
Jun Liu, +86-13985519359, 568955085@qq.com
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Sheng Yan, 13957161680, shengyan@zju.edu.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Hui Zeng, 13989898089, zenghuiray@163.com
- Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang
Zhiwei Li, 15004683651, lzhw0451@163.com
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui
Yifu He, +86-18963789042, 834638033@qq.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Beicheng Sun, +86-5516-2922800, sunbc0207@163.com
- Recruiting
The First Affiliated Hospital of USTC
Hefei, Anhui
Lianxin Liu, 18096656677, liulx@ustc.edu.cn
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Mingjun Zhang, +86-13865952007, mjzhang2010@outlook.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong
Zuoxing Niu, 13506413687, nzxsdth@163.com
- Recruiting
Affiliated Hospital ofJining Medical University
Jining, Shandong
Junye Wang, 18678766866, Jiningwangjunye@163.com
- Recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi
Zhen Liu, +86-13607721261, 16998837@qq.com
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Dianbao Zhang, 15038628192, doctorzhangdianbao@163.com
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan
Xiaobo Du, +86-0816-2230478, duxiaobo2005@126.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Xiaoyong Wei, 13576935622, 41906001@qq.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jianbing Wu, 13507917177, hhgwjb@163.co
- Not yet recruiting
General Hospital of Easten Theater Command
Nanjing, Jiangsu
Xiaoyuan Chu, +86-025-80864750, chuxiaoyuan000@163.com
- Recruiting
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu
Chen Xun, +86-13584015220, xunchen@tysih.com
- Recruiting
The First Affiliated Hospital with NanJing Medical University
Nanjing, Jiangsu
Xiangcheng Li, 18951999088, drxcli@njmu.edu.cn
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Bangde Xiang, +86-13707886124, xiangbangde@163.com
- Recruiting
Nantong Tumor Hospital
Nantong, Jiangsu
Aibing Xu, 13806298983, liurui9092@aliyun.com
- Not yet recruiting
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality
Kui Wang, +86-21-81875242, wangkuiykl@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zhiqiang Meng, 13901711875, mengzhq@yeah.net
- Recruiting
Renji Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Qiang Xia, 13691889035, 1634092111@qq.com
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Huichuan Sun, +86-21-64041990, sun.huichuan@zs-hospital.sh.cn
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning
Qian Dong, 17309815028, dongqian08@163.com
Jingdong Zhang
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Xiujuan Qu, 024-83281560, xjqu@cmu.edu.cn
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Yusheng Wang, +86-13834646436, wangyusheng1972@163.com
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Jinfeng Ma, 15934127269, mjinfeng99@163.com
- Recruiting
TianJin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality
Tongguo Si, 13652089230, drsitg@163.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Feng Zhang, +86-13871410719, zhangfeng_329@126.com
- Recruiting
Tongji Hospital
Wuhan, Hubei
Xiaoping Chen, +86-027-83665312, chenxpchenxp@163.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Jun Xue, 15071258754, xjunion@126.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Xin Zheng, 13649265446, 183421344@qq.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Ling Lv, 13813882571, xyfydb2298@163.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Ping Chen, 13519295282, chenping2536@qq.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Jufeng Wang, +86-13783583966, 13783583966@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhiwei Chang, 13526865540, 13526865540@163.com
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of ABSK-011 Plus Best Supportive Care (BSC) vs. Placebo Plus BSC in Previously Systemically Treated Advanced or Unresectable Hepatocellular Carcinoma Patients With FGF19 Overexpression
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
- Hepatocellular Carcinoma (HCC)
- Being tested
- ABSK-011+BSC, Placebo+BSC
- Keywords
- HCC, FGF19 overexpression, ABSK-011
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK-011+BSCDrug
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+BSCDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | ABSK-011 plus BSC Receives: Drug: ABSK-011+BSC |
| Control arm | Placebo comparator | Placebo plus BSC Receives: Drug: Placebo+BSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR by BICR
Objective response rate (ORR) assessed by Blinded Independent Central Review (BICR) per RECIST v1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR). Patients who receive crossover treatment or start a new anti-tumor therapy prior to achieve an objective response (PR or CR) will be considered as non-responders.
Measured: through study completion, up to 2 years
Secondary outcomes (8)
PFS
Defined as the time (months) from randomization to disease progression or death due to any cause, whichever occurs first.
Measured: through study completion, , up to 2 years
DOR
Defined as the time (months) from the first documented objective response to disease progression or death due to any cause, whichever occurs first.
Measured: through study completion, up to 2 years
DCR
Defined as the proportion of patients achieving CR, PR, or SD (meeting the minimum criteria for SD lasting at least 6 weeks).
Measured: through study completion, up to 2 years
TTP
Defined as the time (months) from randomization to disease progression.
Measured: through study completion, up to 2 years
TTR
Defined as time (months) from randomization to first objective response.
Measured: through study completion, up to 2 years
OS
Defined as the time (months) from randomization to death due to any cause.
Measured: through study completion, up to 2 years
ORR by investigator
Objective response rate (ORR) assessed by the investigator per RECIST v1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
Measured: through study completion, up to 2 years
Adverse events
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and incidence of adverse events leading to dose interruption, dose reduction, and discontinuation of study treatment.
Eastern Cooperative Oncology Group (ECOG) performance status (PS), laboratory tests, electrocardiogram (ECG), vital signs, and physical examination and changes from baseline.
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start13 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327034
- Sponsor's protocol ID
- ABSK-011-205
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of ABSK-011 Plus Best Supportive Care (BSC) vs. Placebo Plus BSC in Previously Systemically Treated Advanced or Unresectable Hepatocellular Carcinoma Patients With FGF19 Overexpression
- ClinicalTrials.gov ID
- NCT07327034
- Acronym / sponsor ID
- ABSK-011-205
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC, FGF19 overexpression, ABSK-011
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: ABSK-011+BSCABSK-011 plus BSC |
| Control arm | Placebo comparator | Drug: Placebo+BSCPlacebo plus BSC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures as per protocol.
- Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form.
- Patients with advanced or unresectable HCC confirmed histologically/cytologically or clinically according to the American Association for the Study of Liver Diseases (AASLD) criteria (for patients with cirrhosis).
- Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI approved for the treatment of HCC.
- BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C.
Key exclusion criteria (22 listed)
- Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo).
- Previous treatment with selective FGFR4 inhibitors.
- Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma.
- Previous anti-tumor therapy is ≤ 4 weeks from randomization.
- Major surgery within 4 weeks prior to randomization; or any surgical wound infection, dehiscence, or incomplete healing within 2 weeks prior to randomization; Or major surgery is planned during study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSK-011+BSCABSK-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. | Drug | Experimental arm |
| Placebo+BSCPlacebo 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. | Drug | Control arm |
Primary outcome
ORR by BICR
Time frame: through study completion, up to 2 years
Objective response rate (ORR) assessed by Blinded Independent Central Review (BICR) per RECIST v1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR). Patients who receive crossover treatment or start a new anti-tumor therapy prior to achieve an objective response (PR or CR) will be considered as non-responders.
8 secondary outcomes
PFS
Time frame: through study completion, , up to 2 years
DOR
Time frame: through study completion, up to 2 years
DCR
Time frame: through study completion, up to 2 years
TTP
Time frame: through study completion, up to 2 years
TTR
Time frame: through study completion, up to 2 years
OS
Time frame: through study completion, up to 2 years
ORR by investigator
Time frame: through study completion, up to 2 years
Adverse events
Time frame: through study completion, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qi Cheng contact
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABSK-011+BSC in people with Hepatocellular Carcinoma (HCC), run by Abbisko Therapeutics Co, Ltd at 51 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Chen (+86-027-83665312, chenxpchenxp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR by BICR (time frame: through study completion, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.