Breast CancerPhase 2NCT07330544
A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy
A Phase 2 study testing entinostat, Fulvestrant and Anlotinib in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+/HER2- with recurrent or progressive advanced breast cancer treated with CDK4/6 inhibitors; The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- entinostat, Fulvestrant and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2025to 26 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign an informed consent form;
- Female, aged 18 or above;
- The patient's Eastern Tumor Collaboration Group (ECOG) physical status is 0-1;
- The patient's expected survival time is ≥3 months;
- Breast cancer patients diagnosed as HR-positive and HER-2 negative by tumor histopathological and molecular pathological typing (based on the most recent report); 1) Hormone receptor positive refers to estrogen receptor (ER) positive, progesterone receptor (PR) negative or positive (≥1% positive staining cells are considered receptor positive); 2) HER-2 negative means: the immunohistochemical result of the pathological specimen test is 0 or 1+; Or an immunohistochemical result of 2+ and a negative ISH or FISH test.
- The subject has received at least one line of endocrine therapy as well as CDK 4/6 inhibitor therapy at an unresectable stage of locally advanced recurrence or metastasis; Or disease recurrence occurred during ET combined with CDK4/6 inhibitors as adjuvant therapy or within 12 months after the end of treatment.
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- The subject has not received chemotherapy or ADC therapy for metastatic disease
- At least one measurable target lesion was evaluated by the investigator in accordance with RECIST 1.1
- No known active brain metastases or leptomeningeal disease
- The patient must have adequate organ function within 1 week (7 days) prior to the initiation of study administration, as defined below:
- Hematology: Hemoglobin (HgB) ≥80 g/L, platelet count ≥100×109 /L, absolute neutrophil count ≥1.0×10 /L.
- Note: Platelet transfusion is not allowed within 3 days before these laboratory tests, red blood cell transfusion is not allowed within 14 days, and hematopoietic growth factor (pegylated G-CSF, 14 days for erythropoietin) is not allowed within 7 days. No blood transfusion or use of auxiliary white blood cell, platelet increase drugs such as cytokines or erythropoietin drugs within 2 weeks prior to the screening test
- Renal function: Serum creatinine (Cre) ≤1.5× upper limit of normal (ULN), or glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2. Urine protein <2+ or 24-hour urine protein quantification <1g
- Liver function: Total bilirubin ≤1.5×ULN; If Gilbert syndrome is present, total bilirubin ≤3 mg/dL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; If there is liver metastasis, both ALT and AST should be ≤5×ULN; Alkaline phosphatase (ALP) ≤2.5×ULN; If there is bone metastasis, it should be ≤5×ULN.
- 9. Echocardiography shows left ejection fraction (LVEF) ≥50% and QTc interval ≤480 ms.
- 10. Female patients in the premenopausal or perimenopausal period who agree to use the concomitant luteinizing hormone-releasing hormone (LHRH) agonist can be enrolled. Those who meet any of the following criteria may be considered to have reached menopause, but those who do not meet the criteria for being considered premenopausal or perimenopausal:
- Having undergone bilateral oophorectomy in the past;
- Age ≥60 years;
- Age <60 years old, natural menopause ≥12 months, no chemotherapy, tamoxifen, torremifen or ovarian function castration during this period, blood follicle-stimulating hormone (FSH) and estradiol (E2) levels within postmenopausal range (judged in combination with the reference range of the research center); 11. Patients who are fertile must agree to use recognized effective methods of contraception (including condoms with inactivated sperm, vaginal separators, oral or injectable contraceptives, etc.) or abstain from sexual activity during their participation in the study and for 3 months after the cessation of study treatment.
Who cannot join
- Patients should not be enrolled if any of the following conditions occur:
- Symptomatic visceral metastases or other conditions, visceral crisis, or the investigator deems it inappropriate to use endocrine therapy;
- The patient has a past or present central nervous system metastases, or leptomeningeal disease, brain metastases;
- Previous use of selective estrogen receptor degraders (SERD, such as fulvestrant) or histone deacetylase (HDAC) inhibitors (such as entectamine, chidamide, etc.) or small molecule multi-target tyrosine kinase inhibitors (such as apatinib, anlotinib, etc.) or PAM pathway inhibitors (such as PI3K inhibitor Alpelisib, AKT inhibitor Capivasertib, MTOR inhibitor everolimus, etc.
- Known allergy to SERD, entinostat, or other drugs with a benzamide structure (such as typapride, remopilib, cloprapride, etc.), anlotinib;
- Pregnant or lactating women;
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- Coexisting with other malignant tumors, unless radical treatment has been administered and there is no evidence of recurrence or metastasis;
- There is pericardial effusion requiring drainage, pleural effusion with obvious clinical symptoms or ascites;
- Other circumstances that the investigator deems unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, 310000
Rong Wang, 18867509858, jiangsuwangrong2006@126.com
About this study
Official title: A Phase II Clinical Study Evaluating Entinostatwit h or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy
- This study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+/HER2- with recurrent or progressive advanced breast cancer treated with CDK4/6 inhibitors;
- The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entestasta + fluvestrus group (Group 1) or the anlotinib + entestasta + fluvestrus group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first.
- During the study period, efficacy evaluations will be conducted every 8 weeks in accordance with the Solid Tumor Efficacy Evaluation Criteria (RECIST) v1.1 until disease progression, the initiation of a new anti-tumor treatment by the subject, or the withdrawal of informed consent, whichever occurs first.
- Continuous safety evaluations will be conducted during the study treatment period. All subjects who have received at least one study treatment will be required to undergo end-of-treatment visits and safety follow-up visits within 7 days and 30±2 days after the last study treatment, respectively.
- The end of the study was defined as the occurrence of disease progression or the end of the study treatment in all subjects, or the early termination of the study for other reasons, whichever occurred first.
- Conditions
- Breast Cancer
- Being tested
- entinostat, Fulvestrant, Anlotinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entinostatDrug
Entinostat tablets, orally once a week (5 mg); Each treatment cycle lasts for 28 days. Treatment will continue until the subject experiences disease progression, intolerable toxicity, voluntary withdrawal, or any other condition specified in the protocol, whichever occurs first.
FulvestrantDrug
Fulvestrant, intramuscular injection, 500 mg each time, administered on d1 and d15 of the first cycle, and on d1 of each subsequent cycle. Each treatment cycle lasts for 28 days. Treatment will continue until the subject experiences disease progression, intolerable toxicity, voluntary withdrawal, or any other condition specified in the protocol, whichever occurs first.
AnlotinibDrug
Anlotinib, 10mg each time, once daily, orally before breakfast. Take the drug for 2 consecutive weeks and then stop for 1 week, that is, 3 weeks (21 days) as one course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| entinostat + fulvestrant | Experimental | Entinostat tablets Dosage form: Tablets Specification Appearance: 1.0 mg (pink to pale red) or 5.0 mg/ tablet (yellow) Dosage and Administration: 1 tablet (5 mg/ tablet) once a week, orally administered. Take at least 1 hour before meals or at least 2 hours after meals.
Combination therapy:
Fulvestrant injection Dosage form: Injection Appearance: A clear, viscous, colorless to yellowish liquid Specification: 5 ml; 0.25g per vial Dosage and Administration: 500 mg by intramuscular injection. Each 28-day treatment cycle is administered on day 1 and day 15 of the first cycle, followed by day 1 of each subsequent cycle Receives: Drug: entinostat; Drug: Fulvestrant |
| entinostat + fulvestrant+anlotinib | Experimental | Entinostat tablets Dosage form: Tablets Specification Appearance: 1.0 mg (pink to pale red) or 5.0 mg/ tablet (yellow) Dosage and Administration: 1 tablet (5 mg/ tablet) once a week, orally administered. Take at least 1 hour before meals or at least 2 hours after meals.
Combination therapy:
Fulvestrant injection Dosage form: Injection Appearance: A clear, viscous, colorless to yellowish liquid Specification: 5 ml; 0.25g per vial Dosage and Administration: 500 mg by intramuscular injection. Each 28-day treatment cycle is administered on day 1 and day 15 of the first cycle, followed by day 1 of each subsequent cycle Anlotinib capsules Dosage form: Capsule Appearance: White or off-white powder or granules Dosage and Administration: The recommended dose is 10mg each time, once daily, orally before breakfast. Continuous administration 2 weeks, then 1 week off, that is 3 weeks (21 days) as one course of treatment. Receives: Drug: entinostat; Drug: Fulvestrant; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To evaluate the objective response rate (ORR) of entinostat combined with fulvestrant in the treatment of HR+/HER2- advanced breast cancer that has recurred or progressed after CDK4/6 inhibitor therapy.
Objective response rate was defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses were evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).
Measured: Up to 2 years
Secondary outcomes (3)
PFS
To evaluate progression-free survival (PFS),of entinostat with or without anlotinib + fulvestrant in treatment of relapsed or advanced HR+/HER2- breast cancer treated with CDK4/6 inhibitors
Progression-free survival (PFS) was defined to be time from randomization to the earliest documented disease progression as defined by the RECIST criteria, new primary breast cancer, or death without progression. The distribution of PFS will be estimated using the Kaplan- Meier method, with 95% confidence intervals calculated using Greenwood's formula. In the primary analysis of PFS, differences in treatment effect will be tested using stratified log rank tests, stratifying on the randomization stratification factors. Stratified univariate and multivariable Cox proportional-hazard models will be built to estimate the hazard ratios (HRs) for treatment effect for PFS as a supportive analysis. In all analyses, P-values will be two-sided.
Measured: Up to 2 years
CBR
To evaluate clinical benefit rate (CBR) of entinostat with or without anlotinib + fulvestrant in treatment of relapsed or advanced HR+/HER2- breast cancer treated with CDK4/6 inhibitors
Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks
Measured: up to 2 years
DoR
To evaluate duration of response (DoR) of entinostat with or without anlotinib + fulvestrant in treatment of relapsed or advanced HR+/HER2- breast cancer treated with CDK4/6 inhibitors
Measured: Date of CR or PR to date of disease progression or death due to any cause (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 posted9 Jan 2026
- Study start24 Nov 2025
- Primary completion25 Nov 2027 (estimated)
- Study completion26 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Model description
- The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entinostat + fluvestrant group (Group 1) or the anlotinib + entinostat + fluvestrant group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first.
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Hai, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330544
- Sponsor's protocol ID
- EAF-BC-IIT-001
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study Evaluating Entinostatwit h or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy
- ClinicalTrials.gov ID
- NCT07330544
- Acronym / sponsor ID
- EAF-BC-IIT-001
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 25 Nov 2027 (estimated)
- Study completion
- 26 Nov 2028 (estimated)
- First posted
- 9 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 study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+/HER2- with recurrent or progressive advanced breast cancer treated with CDK4/6 inhibitors;
- The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entestasta + fluvestrus group (Group 1) or the anlotinib + entestasta + fluvestrus group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first.
- During the study period, efficacy evaluations will be conducted every 8 weeks in accordance with the Solid Tumor Efficacy Evaluation Criteria (RECIST) v1.1 until disease progression, the initiation of a new anti-tumor treatment by the subject, or the withdrawal of informed consent, whichever occurs first.
- Continuous safety evaluations will be conducted during the study treatment period. All subjects who have received at least one study treatment will be required to undergo end-of-treatment visits and safety follow-up visits within 7 days and 30±2 days after the last study treatment, respectively.
- The end of the study was defined as the occurrence of disease progression or the end of the study treatment in all subjects, or the early termination of the study for other reasons, whichever occurred first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entinostat + fluvestrant group (Group 1) or the anlotinib + entinostat + fluvestrant group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first.
| Arm | Type | Receives |
|---|---|---|
| entinostat + fulvestrant | Experimental | Drug: entinostat, Drug: FulvestrantEntinostat tablets Dosage form: Tablets Specification Appearance: 1.0 mg (pink to pale red) or 5.0 mg/ tablet (yellow) Dosage and Administration: 1 tablet (5 mg/ tablet) once a week, orally administered. Take at least 1 hour before meals or at least 2 hours after meals. Combination therapy: Fulvestrant injection Dosage form: Injection Appearance: A clear, viscous, colorless to yellowish liquid Specification: 5 ml; 0.25g per vial Dosage and Administration: 500 mg by intramuscular injection. Each 28-day treatment cycle is administered on day 1 and day 15 of the first cycle, followed by day 1 of each subsequent cycle |
| entinostat + fulvestrant+anlotinib | Experimental | Drug: entinostat, Drug: Fulvestrant, Drug: AnlotinibEntinostat tablets Dosage form: Tablets Specification Appearance: 1.0 mg (pink to pale red) or 5.0 mg/ tablet (yellow) Dosage and Administration: 1 tablet (5 mg/ tablet) once a week, orally administered. Take at least 1 hour before meals or at least 2 hours after meals. Combination therapy: Fulvestrant injection Dosage form: Injection Appearance: A clear, viscous, colorless to yellowish liquid Specification: 5 ml; 0.25g per vial Dosage and Administration: 500 mg by intramuscular injection. Each 28-day treatment cycle is administered on day 1 and day 15 of the first cycle, followed by day 1 of each subsequent cycle Anlotinib capsules Dosage form: Capsule Appearance: White or off-white powder or granules Dosage and Administration: The recommended dose is 10mg each time, once daily, orally before breakfast. Continuous administration 2 weeks, then 1 week off, that is 3 weeks (21 days) as one course of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Sign an informed consent form;
- Female, aged 18 or above;
- The patient's Eastern Tumor Collaboration Group (ECOG) physical status is 0-1;
- The patient's expected survival time is ≥3 months;
- Breast cancer patients diagnosed as HR-positive and HER-2 negative by tumor histopathological and molecular pathological typing (based on the most recent report); 1) Hormone receptor positive refers to estrogen receptor (ER) positive, progesterone receptor (PR) negative or positive (≥1% positive staining cells are considered receptor positive); 2) HER-2 negative means: the immunohistochemical result of the pathological specimen test is 0 or 1+; Or an immunohistochemical result of 2+ and a negative ISH or FISH test.
Key exclusion criteria (9 listed)
- Patients should not be enrolled if any of the following conditions occur:
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 |
|---|---|---|
| entinostatEntinostat tablets, orally once a week (5 mg); Each treatment cycle lasts for 28 days. Treatment will continue until the subject experiences disease progression, intolerable toxicity, voluntary withdrawal, or any other condition specified in the protocol, whichever occurs first. | Drug | entinostat + fulvestrant, entinostat + fulvestrant+anlotinib |
| FulvestrantFulvestrant, intramuscular injection, 500 mg each time, administered on d1 and d15 of the first cycle, and on d1 of each subsequent cycle. Each treatment cycle lasts for 28 days. Treatment will continue until the subject experiences disease progression, intolerable toxicity, voluntary withdrawal, or any other condition specified in the protocol, whichever occurs first. | Drug | entinostat + fulvestrant, entinostat + fulvestrant+anlotinib |
| AnlotinibAnlotinib, 10mg each time, once daily, orally before breakfast. Take the drug for 2 consecutive weeks and then stop for 1 week, that is, 3 weeks (21 days) as one course of treatment. | Drug | entinostat + fulvestrant+anlotinib |
Primary outcome
ORR
Time frame: Up to 2 years
To evaluate the objective response rate (ORR) of entinostat combined with fulvestrant in the treatment of HR+/HER2- advanced breast cancer that has recurred or progressed after CDK4/6 inhibitor therapy. Objective response rate was defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses were evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).
3 secondary outcomes
PFS
Time frame: Up to 2 years
CBR
Time frame: up to 2 years
DoR
Time frame: Date of CR or PR to date of disease progression or death due to any cause (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 9 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing entinostat, Fulvestrant and Anlotinib in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site 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 19 inclusion and 9 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 9 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 1 site 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 Rong Wang (18867509858, jiangsuwangrong2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 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 9 Jan 2026.