Alveolar Soft Part SarcomaPhase 2NCT07548177
Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma
A Phase 2 study testing Benmelstobart injection combined with Anlotinib hydrochloride capsule in people with Alveolar Soft Part Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 sites in China.
Trial summary
This is a Phase II, single-arm, multicenter clinical study aimed at demonstrating the effectiveness of benmelstobart injection combined with anlotinib hydrochloride capsules in patients aged 14 years or older with advanced or unresectable alveolar soft part sarcoma by evaluating the objective response rate (IRC). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Alveolar Soft Part Sarcoma
- What is being tested?
- Benmelstobart injection combined with Anlotinib hydrochloride capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 15 sitesChina
- Study dates
- 2 Apr 2026to Nov 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only when all the following criteria are met will the subjects be eligible for inclusion in this study:
- The subjects voluntarily join this study, sign the informed consent form, and have good compliance;
- ≥14 years old (calculated from the date of signing the informed consent form);
- Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 1;
- Expected survival greater than 12 weeks;
- Pathologically confirmed recurrent and/or metastatic or unresectable alveolar soft part sarcoma, without previous systemic treatment;
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- Confirmed to have at least one measurable lesion according to RECIST 1.1;
- Laboratory tests meet the following standards:
- Hemoglobin (HGB) ≥ 90g/L;
- Absolute neutrophil count (NEUT) ≥ 1.5×109/L;
- Platelet count (PLT) ≥ 100×109/L.
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If there is liver metastasis, ALT and AST ≤ 5 ULN;
- Serum creatinine (CR) ≤ 1.5 ULN or creatinine clearance rate (CCR) ≥ 60ml/min;
- Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (if not receiving anticoagulant therapy);
- Thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, the subject can be included.
- Women of childbearing age must agree to use effective contraceptive measures during the study and for 6 months after the study, and have a negative serum test within 7 days before study enrollment; men must agree to use effective contraceptive measures during the study and for 6 months after the study.
Who cannot join
- Any subject meeting any of the following criteria will be excluded from this trial:
- Having had or currently having another malignant tumor within 5 years before the first administration of the drug. The following two situations are eligible for inclusion: other malignant tumors treated with a single surgery and achieving a disease-free survival (DFS) of at least 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)].
- Having diseases that affect intravenous injection or blood collection, or having multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.).
- Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score of ≤1, except for grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which are judged by the investigator to have no safety risks.
- Having undergone major surgery, significant traumatic injury, or expected to undergo major surgery during the study period within 4 weeks before the first administration of the drug (except for surgeries specified in the protocol), or having long-term unhealed wounds or fractures. (Major surgery is defined as: surgeries classified as grade 3 or above in the 2023 version of the surgical classification directory of the participating center).
- Having experienced any bleeding or hemorrhagic event ≥ CTCAE grade 3 within 4 weeks before the first administration of the drug.
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- Having experienced an arterial or venous thrombotic event within 6 months before the first administration of the drug, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
- Active viral hepatitis that is not well controlled. Subjects meeting the following requirements can be screened: HBsAg-positive subjects must have Hepatitis B Virus (HBV) DNA quantification < 2000 IU/ml (or 1*104 copies/ml) or have received at least 1 week of antiviral treatment for HBV before the start of the study and have a 10-fold (1 log value) or greater reduction in viral index, and be willing to receive antiviral treatment throughout the study; HCV-infected subjects (HCV Ab or HCV RNA positive): judged by the investigator to be in a stable state or receiving antiviral treatment at the time of enrollment and continuing to receive approved antiviral treatment during the study.
- Active syphilis infection requiring treatment.
- Having active tuberculosis, a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms.
- Having a history of substance abuse of psychotropic drugs and being unable to quit or having a mental disorder.
- Preparing for or having previously received allogeneic bone marrow transplantation or solid organ transplantation.
- Having major cardiovascular diseases, including any of the following conditions:
- Cardiac insufficiency of New York Heart Association Functional Classification (NYHA) class II or above or echocardiography showing left ventricular ejection fraction (LVEF) < 50%;
- History of clinically significant ventricular arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia) or arrhythmias requiring continuous antiarrhythmic drug treatment;
- Unstable angina pectoris;
- Myocardial infarction within 12 months;
- Fridericia-corrected QT interval (QTcF) > 450 milliseconds (msec) for men and > 470 msec for women (if QTc is abnormal, it can be continuously measured three times with an interval of more than 2 minutes, and the average value is taken);
- History or family history of congenital long QT syndrome. 7) A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolic event within 3 months prior to randomization (implantable venous access ports or catheter-related thrombosis, or superficial venous thrombosis are not considered "serious" thromboembolic events);
- Currently using or having used within 7 days prior to the start of study treatment aspirin (>325 mg/day (maximum antiplatelet dose)), dipyridamole, ticlopidine, clopidogrel, or cilostazol;
- Active or uncontrolled severe infection (≥CTC AE grade 2 infection);
- Renal failure requiring hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
- Subjects who need to use immunosuppressants, systemic or absorbable local hormones for immunosuppression purposes and will continue to do so within 7 days before the first administration (except for glucocorticoids at a daily dose of <10 mg prednisone or other equivalent efficacy hormones);
- Patients with epilepsy requiring treatment;
- Tumor-related symptoms and treatment:
- Having received treatment with traditional Chinese patent medicines with clear anti-tumor indications in the National Medical Products Administration (NMPA)-approved drug instructions (including Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea javanica Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Chan Su Capsules, etc.) within 2 weeks prior to the start of study treatment;
- Having received previous treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, or Cytotoxic T-Lymphocyte-Associated Antigen 4 (CTLA-4);
- Having previously used anti-angiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, or fruquintinib;
- Having received treatment with drugs with immunomodulatory functions (such as interleukin-2, thymosin, polysaccharides from Lentinus edodes, etc.) within 30 days prior to the start of treatment;
- Not having recovered from the toxicity and/or complications of previous interventions to CTCAE ≤ grade 1, except for alopecia and peripheral neuropathy ≤ grade 2. ；
- Imaging studies (CT or MRI) show that the tumor has invaded major blood vessels or the investigator deems that the tumor is highly likely to invade major blood vessels and cause fatal hemorrhage during the subsequent study period;
- Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites (as judged by the investigator) that requires repeated drainage;
- Known to have spinal cord compression, carcinomatous meningitis, brain metastases with symptoms or symptoms controlled for less than 4 weeks.
- Known to be allergic to the excipients of the study drug.
- Participants who have taken part in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration of the study drug.
- As judged by the investigator, there are serious conditions that endanger the safety of the participant or affect the participant's completion of the study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jiayong Liu, Doctor, 13641103227, liujiayong@aliyun.com
- Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Di Wu, Doctor, 13944888991, wudi888991@163.com
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Bin Li, Doctor, 13467713587, 691388939@qq.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Yu Jiang, Doctor, 18980601130, jiangyuwork@126.com
- Not yet recruiting
The First Affiliated Hospital of Army Medical University of the People's Liberation Army of China
Chongqing, Chongqing Municipality, 400038
Jianjun LI, Doctor, 13608319428, leejjun2007@163.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangdong, Guangdong, 510060
Xing Zhang, Doctor, 13610223691, zhangxing@sysucc.org.com
- Not yet recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine.
Hangzhou, Zhejiang, 310009
Ying Dong, Doctor, 13666669105, dy7412@126.com
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
MeiYu Fang, Master, 0571-88122188, fangmy@zjcc.org.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qingyu Shi, Doctor, 13936574133, sanyuanguke@126.com
- Not yet recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, 250117
Dongyuan Zhu, Doctor, 18954516655, 405683898@qq.com
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Yingqi Hua, Doctor, 13817651474, hua_yingqi@163.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jilong Yang, Doctor, 18622221626, yangjilong@tjmuch.com
- Not yet recruiting
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, 830000
Renbin Jiang, Doctor, 13999153829, 1911452679@qq.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Jing Chen, Doctor, 15807183251, chenjingunion@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Weitao Yao, Master, 15838008899, ywtwhm@163.com
About this study
Official title: To Evaluate the Single-arm, Multi-center Phase II Clinical Trial of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma
This is a Phase II, single-arm, multicenter clinical study aimed at demonstrating the effectiveness of benmelstobart injection combined with anlotinib hydrochloride capsules in patients aged 14 years or older with advanced or unresectable alveolar soft part sarcoma by evaluating the objective response rate (IRC).
- Conditions
- Alveolar Soft Part Sarcoma
- Being tested
- Benmelstobart injection combined with Anlotinib hydrochloride capsule
- Medical subject headings
- Sarcoma, Alveolar Soft Part
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benmelstobart injection combined with Anlotinib hydrochloride capsuleDrug
Benmelstobart is a PD-L1 immunosuppressant. Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Benmelstobart injection+Anlotinib Hydrochloride Capsules | Experimental | Benmelstobart injection combined with Anlotinib hydrochloride capsules, with a 21-day cycle. Receives: Drug: Benmelstobart injection combined with Anlotinib hydrochloride capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (IRC assessment)
The proportion of patients with tumor volume reduction reaching 30% is usually the sum of the proportions of complete response (CR) and partial response (PR). (IRC Assessment)
Measured: The period from baseline to the end of the trial is expected to be 32 months.
Secondary outcomes (15)
Disease control rate (IRC assessment)
The proportion of cases that achieved remission (CR+PR) and disease stability (SD) after treatment, that is, the proportion of patients who did not experience disease progression (PD). (IRC Assessment)
Measured: The period from baseline to the end of the trial is expected to be 32 months.
Duration of remission (IRC assessment)
The duration from the first significant shrinkage of the tumor to its subsequent enlargement/progression (IRC assessment)
Measured: The period from baseline to the end of the trial is expected to be 32 months.
Progression-free survival (IRC assessment)
From the time of random initiation to the occurrence of a predetermined event, an event may include death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.(IRC assessment)
Measured: The period from baseline to the end of the trial is expected to be 32months.
12-month progression-free survival rate (IRC assessment)
The proportion of subjects whose condition did not deteriorate or progress from the start of treatment to 12 months (IRC assessment)
Measured: From baseline to 12 months after treatment
24-month progression-free survival rate (IRC assessment)
The proportion of subjects whose condition did not deteriorate or progress from the start of treatment to 24 months (IRC assessment)
Measured: From baseline to 24 months after treatment
36-month progression-free survival rate (IRC assessment)
The proportion of subjects whose condition did not deteriorate or progress from the start of treatment to 36 months (IRC assessment)
Measured: From baseline to 36 months after treatment
Objective response rate (Researcher Evaluation)
The proportion of patients with tumor volume reduction reaching 30% is usually the sum of the proportions of complete response (CR) and partial response (PR). (Researcher Evaluation)
Measured: The period from baseline to the end of the trial is expected to be 32 months.
Disease control rate(Researcher Evaluation)
The proportion of cases that achieved remission (CR+PR) and disease stability (SD) after treatment, that is, the proportion of patients who did not experience disease progression (PD). (Researcher Evaluation)
Measured: The period from baseline to the end of the trial is expected to be 32 months.
Duration of remission(Researcher Evaluation)
The duration from the first significant shrinkage of the tumor to its subsequent enlargement/progression(Researcher Evaluation)
Measured: The period from baseline to the end of the trial is expected to be 32 months.
Progression-free survival (Researcher Evaluation)
The time from the start of treatment to disease progression or death for any reason (Researcher Evaluation)
Measured: The period from baseline to the end of the trial is expected to be 32 months.
The 12-month progression-free survival rate(Researcher Evaluation)
The proportion of subjects whose condition did not deteriorate or progress from the start of treatment to 12 months (Researcher Evaluation)
Measured: From baseline to 12 months after treatment
24-month progression-free survival rate(Researcher Evaluation)
The proportion of subjects whose condition did not deteriorate or progress from the start of treatment to 24 months (Researcher Evaluation)
Measured: From baseline to 24 months after treatment
36-month progression-free survival rate (Researcher Evaluation)
The proportion of subjects whose conditions did not deteriorate or progress from the start of treatment to 36 months(Researcher Evaluation)
Measured: From baseline to 36 months after treatment
Overall survival
The time of death from the start of treatment to any cause of death.
Measured: Baseline to death (estimated 48 months)
Numbers of subject with the incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators
Numbers of subject with the incidence and severity of adverse events (AE) and serious adverse events (SAE) that occurred during the trial, as well as abnormal laboratory test indicators
Measured: The period from baseline to the end of the trial is expected to be 32 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start2 Apr 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Soft Part SarcomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548177
- Sponsor's protocol ID
- TQB2450-ALTN-II-04
- Status last verified
- Nov 2025
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Single-arm, Multi-center Phase II Clinical Trial of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma
- ClinicalTrials.gov ID
- NCT07548177
- Acronym / sponsor ID
- TQB2450-ALTN-II-04
- Conditions
- Alveolar Soft Part Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 23 Apr 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 Phase II, single-arm, multicenter clinical study aimed at demonstrating the effectiveness of benmelstobart injection combined with anlotinib hydrochloride capsules in patients aged 14 years or older with advanced or unresectable alveolar soft part sarcoma by evaluating the objective response rate (IRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benmelstobart injection+Anlotinib Hydrochloride Capsules | Experimental | Drug: Benmelstobart injection combined with Anlotinib hydrochloride capsuleBenmelstobart injection combined with Anlotinib hydrochloride capsules, with a 21-day cycle. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Only when all the following criteria are met will the subjects be eligible for inclusion in this study:
Key exclusion criteria (37 listed)
- Any subject meeting any of the following criteria will be excluded from this trial:
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 |
|---|---|---|
| Benmelstobart injection combined with Anlotinib hydrochloride capsuleBenmelstobart is a PD-L1 immunosuppressant. Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor. | Drug | Benmelstobart injection+Anlotinib Hydrochloride Capsules |
Primary outcome
Objective response rate (IRC assessment)
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
The proportion of patients with tumor volume reduction reaching 30% is usually the sum of the proportions of complete response (CR) and partial response (PR). (IRC Assessment)
15 secondary outcomes
Disease control rate (IRC assessment)
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
Duration of remission (IRC assessment)
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
Progression-free survival (IRC assessment)
Time frame: The period from baseline to the end of the trial is expected to be 32months.
12-month progression-free survival rate (IRC assessment)
Time frame: From baseline to 12 months after treatment
24-month progression-free survival rate (IRC assessment)
Time frame: From baseline to 24 months after treatment
36-month progression-free survival rate (IRC assessment)
Time frame: From baseline to 36 months after treatment
Objective response rate (Researcher Evaluation)
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
Disease control rate(Researcher Evaluation)
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
Duration of remission(Researcher Evaluation)
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
Progression-free survival (Researcher Evaluation)
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
The 12-month progression-free survival rate(Researcher Evaluation)
Time frame: From baseline to 12 months after treatment
24-month progression-free survival rate(Researcher Evaluation)
Time frame: From baseline to 24 months after treatment
36-month progression-free survival rate (Researcher Evaluation)
Time frame: From baseline to 36 months after treatment
Overall survival
Time frame: Baseline to death (estimated 48 months)
Numbers of subject with the incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators
Time frame: The period from baseline to the end of the trial is expected to be 32 months.
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 23 Apr 2026.
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Active, not recruitingPhase 2
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
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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.
15 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 Benmelstobart injection combined with Anlotinib hydrochloride capsule in people with Alveolar Soft Part Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 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 17 inclusion and 37 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. 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 Jiayong Liu, Doctor (13641103227, liujiayong@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (IRC assessment) (time frame: The period from baseline to the end of the trial is expected to be 32 months.). 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 23 Apr 2026.