HER2-positive Breast CancerPhase 3NCT06107790

Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer

A Phase 3 study testing HS022, Trastuzumab and Vinorelbine Bitartrate in people with HER2-positive Breast Cancer, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety and Immunogenicity of Vinorelbine Bitartrate Injection in Combination With HS022 and Trastuzumab®.There were 2 parts. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: HER2-positive Breast Cancer
What is being tested?: HS022, Trastuzumab and Vinorelbine Bitartrate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 570 participants
Where: 1 siteChina
Study dates: 16 May 2018to 28 Jan 2022
Phase: Phase 3
Are there results?: None posted in the registry

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 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Female ≥18 and ≤75 years of age on day of signing the informed consent form (ICF).
2. Histologically or cytologically confirmed adenocarcinoma of the breast. 3. Recurrent disease not amenable to curative surgery or radiation therapy. 4. HER2-positivity, based on IHC score 3+ or ISH positivity. For those IHC score 2+ patients, fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH) or silver enhanced in situ hybridization (SISH) should be tested to prove HER2 gene amplification.
5.No prior systemic anticancer agent such as chemotherapy, biological or targeted agent for metastatic disease. For patients with recurrent disease, prior neo-/adjuvant therapy containing trastuzumab must have been stopped at least 12 months before the diagnosis of recurrent (local or metastatic) disease.
6.Those with at least one measurable target lesion (RECIST 1.1 standard): at least one diameter line of the target lesion can be accurately measured, and the lesions, skin lesions, brain lesions, and bone metastases of any type after radiotherapy or other local regional treatment can only be evaluated as non-target lesions; 7.ECOG < 2； 8.Left ventricular ejection fraction (LVEF) ≥ 50% within 4 weeks before randomization; 9.Adequate hematology, liver function and kidney function, as shown in the following laboratory test values；
.a) Absolute value of neutrophil ≥ 1.5 × 109/L； b) Platelet ≥ 100 × 109/L, and hemoglobin ≥ 90g/L; c) Total serum bilirubin ≤ 1.5 times the upper limit of normal value (except for Gilbert syndrome); d) ALT and AST ≤ 2.5 times the upper limit of normal value (subjects with liver metastasis ≤ 5 times the upper limit of normal value); e) Blood creatinine ≤ 1.5 times the upper limit of normal value. 10.The expected survival period ≥ 3 months. 11. Patients have voluntarily agreed to participate and given written informed consent.

Who cannot join

.Prior surgery within 4 weeks preceeding enrollment or expected to be performed during the trial, prior chemotherapy wihtin 4 weeks preceeding enrollment, prior radiotherapy or endocrinotherapy within 4 weeks before enrollment.
2.Prior treatment with vinorelbine 3.Current peripheral neuropathy above 2 grades 4.Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. Central nervous system metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomography (CT) or magnetic resonance imaging (MRI) scan for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
5.Participation in another clinical study within 4 weeks before enrollment (3 months for studies involving monoclonal therapy), excluding those who failed in screening;
6. Patients with any other malignant tumor in the past five years, excluding fully cured cervical carcinoma in situ, basal cell or squamous cell skin cancer;
7. Have a clear history of neurological or mental disorders, including epilepsy or dementia;
8. Those who are allergic to any ingredient or excipient of the test drug, including those who are allergic to benzyl alcohol;

Show all 16Show fewer

9. Those who have received whole blood or component blood transfusion within 2 weeks before randomization;
10. Those who currently suffer from diseases affecting intravenous injection and venous blood collection;
11. At present, there are serious and uncontrollable systemic diseases (such as dyspnea, bronchospasm, acute attack of asthma or other diseases requiring continuous oxygen inhalation treatment), which, according to the judgment of the researcher, will significantly affect the participation/completion of the test and efficacy evaluation of the subjects;
12. Have any of the following heart diseases:
Currently suffering from untreated or uncontrollable hypertension (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg), or unstable angina pectoris;
According to the standards of the New York Heart Association, he currently has a history of congestive heart failure at any level, or serious arrhythmia requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia);
Myocardial infarction occurred within 6 months before signing the informed consent;
13. At present, people who need to use corticosteroids daily for long-term treatment (the equivalent dose of methylprednisolone with dose>10 mg/day), excluding inhaled corticosteroids; 14. Any one of human immunodeficiency virus antibody, treponema pallidum antibody and hepatitis C virus antibody should be excluded. Or there are patients with active hepatitis B infection of clinical significance who need treatment: hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb] is positive, and hepatitis B virus deoxyribonucleic acid [HBV DNA] test results are greater than or equal to the upper limit of the reference value of each hospital. Among them, only those with positive syphilis specific antibody test but negative syphilis non-specific antibody test can be selected; Only those with positive hepatitis C virus antibody but negative hepatitis C virus RNA [HCV RNA] can be selected;;
15. Pregnant or lactating women; Or when screening, the blood pregnancy test of women of childbearing age is positive; Or women of childbearing age and their spouses are unwilling to take effective contraceptive measures during and within 7 months after the end of the clinical trial;
The researcher believes that it is not suitable for enrollment or may not be able to complete the test for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Province People's Hospital (First Affiliated Hospital of Nanjing Medical University)
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Conditions: HER2-positive Breast Cancer
Being tested: HS022, Trastuzumab, Vinorelbine Bitartrate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HS022Drug
8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg
TrastuzumabDrug
8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg
Vinorelbine BitartrateDrug
Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). 3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
Second section:9 treatment cycles, 3 weeks/cycle, 27 weeks. Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). The investigator may decide whether to continue treatment with vinorelbine at his discretion.
3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.

Study groups in NCT06107790
Study group	Role	What they receive
HS022+ Vinorelbine Bitartrate	Experimental	Not described Receives: Drug: HS022; Drug: Vinorelbine Bitartrate
Trastuzumab®+ Vinorelbine Bitartrate Injection	Active comparator	Not described Receives: Drug: Trastuzumab; Drug: Vinorelbine Bitartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR
The best overall response rate (ORR24: performed at the 25th week): According to the Solid Tumor Efficacy Evaluation Standard (RECIST) 1.1, the proportion of CR and PR subjects from the first evaluation (baseline) to the 25th week of treatment (after the completion of 8 treatment cycles) (note: including unconfirmed response).
Measured: WEEK 25

Secondary outcomes (13)

DCR
Disease control rate (DCR: in the 25th week): DCR=CR+PR+SD。
Measured: WEEK 25
PFS
Progression-free survival (PFS: the 52nd week): according to RECIST1.1, the time from the date of randomization to the date of disease progression or all-cause death (whichever occurs first). If the subjects did not have the above events, the PFS would be closed to the date of the last full tumor evaluation.
Measured: WEEK 52
OS
Total survival rate (OS rate: performed at the 52nd week): defined as the percentage of subjects who survived at 51 weeks after randomization.
Measured: WEEK 52
Vital signs
temprature
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
pulse rate
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
respiration（in times/minute）
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
blood pressure (systolic/diastolic，in mmHg)
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
physical examination,
Perform a physical examination at each visit
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
ADAs
The incidence of anti-drug antibodies (ADAs) before treatment, after 2 cycles of treatment, after 4 cycles, after 6 cycles, after 8 cycles, after 12 cycles, on the 22nd day after the last administration of 17 cycles/on the 22nd day after the last administration (test/non test drug) of early withdrawal
Measured: on the 22nd day after the last administration
Ctrough
Collect serum samples for PK testing according to the protocol/laboratory manual, and transport them to the biological sample analysis laboratory for unified testing and analysis
Measured: In two hours before the administration of the trial drug on the first day of the 1st, 3rd, 5th and 7th cycles, the 22nd day of the 8th cycle)/the 22nd day after the last administration. Each cycle was 21 days.
ECOG physical condition
ECOG physical condition
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
left ventricular ejection fraction (LVEF),
left ventricular ejection fraction (LVEF),
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
adverse events (AE)
adverse events (AE)
Measured: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 201828 Jan 2022

First posted30 Oct 2023
Study start16 May 2018
Primary completion28 Jan 2022
Study completion28 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 570 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06107790
Sponsor's protocol ID: HS022-III
Status last verified: Sep 2023
First submitted: 16 Mar 2023
Last updated: 30 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HER2-positive Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer
ClinicalTrials.gov ID: NCT06107790
Acronym / sponsor ID: HS022-III
Conditions: HER2-positive Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 570 participants (actual)
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Study start: 16 May 2018 (actual)
Primary completion: 28 Jan 2022 (actual)
Study completion: 28 Jan 2022 (actual)
First posted: 30 Oct 2023 (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.

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
HS022+ Vinorelbine Bitartrate	Experimental	Drug: HS022, Drug: Vinorelbine Bitartrate
Trastuzumab®+ Vinorelbine Bitartrate Injection	Active comparator	Drug: Trastuzumab, Drug: Vinorelbine Bitartrate

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

1. Female ≥18 and ≤75 years of age on day of signing the informed consent form (ICF).
2. Histologically or cytologically confirmed adenocarcinoma of the breast. 3. Recurrent disease not amenable to curative surgery or radiation therapy. 4. HER2-positivity, based on IHC score 3+ or ISH positivity. For those IHC score 2+ patients, fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH) or silver enhanced in situ hybridization (SISH) should be tested to prove HER2 gene amplification.
5.No prior systemic anticancer agent such as chemotherapy, biological or targeted agent for metastatic disease. For patients with recurrent disease, prior neo-/adjuvant therapy containing trastuzumab must have been stopped at least 12 months before the diagnosis of recurrent (local or metastatic) disease.
6.Those with at least one measurable target lesion (RECIST 1.1 standard): at least one diameter line of the target lesion can be accurately measured, and the lesions, skin lesions, brain lesions, and bone metastases of any type after radiotherapy or other local regional treatment can only be evaluated as non-target lesions; 7.ECOG < 2； 8.Left ventricular ejection fraction (LVEF) ≥ 50% within 4 weeks before randomization; 9.Adequate hematology, liver function and kidney function, as shown in the following laboratory test values；
.a) Absolute value of neutrophil ≥ 1.5 × 109/L； b) Platelet ≥ 100 × 109/L, and hemoglobin ≥ 90g/L; c) Total serum bilirubin ≤ 1.5 times the upper limit of normal value (except for Gilbert syndrome); d) ALT and AST ≤ 2.5 times the upper limit of normal value (subjects with liver metastasis ≤ 5 times the upper limit of normal value); e) Blood creatinine ≤ 1.5 times the upper limit of normal value. 10.The expected survival period ≥ 3 months. 11. Patients have voluntarily agreed to participate and given written informed consent.

Key exclusion criteria (16 listed)

.Prior surgery within 4 weeks preceeding enrollment or expected to be performed during the trial, prior chemotherapy wihtin 4 weeks preceeding enrollment, prior radiotherapy or endocrinotherapy within 4 weeks before enrollment.
2.Prior treatment with vinorelbine 3.Current peripheral neuropathy above 2 grades 4.Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. Central nervous system metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomography (CT) or magnetic resonance imaging (MRI) scan for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
5.Participation in another clinical study within 4 weeks before enrollment (3 months for studies involving monoclonal therapy), excluding those who failed in screening;
6. Patients with any other malignant tumor in the past five years, excluding fully cured cervical carcinoma in situ, basal cell or squamous cell skin cancer;
7. Have a clear history of neurological or mental disorders, including epilepsy or dementia;

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
HS0228 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first. The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg	Drug	HS022+ Vinorelbine Bitartrate
Trastuzumab8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first. The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg	Drug	Trastuzumab®+ Vinorelbine Bitartrate Injection
Vinorelbine BitartrateVinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). 3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first. Second section:9 treatment cycles, 3 weeks/cycle, 27 weeks. Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). The investigator may decide whether to continue treatment with vinorelbine at his discretion. 3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.	Drug	HS022+ Vinorelbine Bitartrate, Trastuzumab®+ Vinorelbine Bitartrate Injection

Primary outcome

ORR
Time frame: WEEK 25
The best overall response rate (ORR24: performed at the 25th week): According to the Solid Tumor Efficacy Evaluation Standard (RECIST) 1.1, the proportion of CR and PR subjects from the first evaluation (baseline) to the 25th week of treatment (after the completion of 8 treatment cycles) (note: including unconfirmed response).

13 secondary outcomes

DCR
Time frame: WEEK 25
PFS
Time frame: WEEK 52
OS
Time frame: WEEK 52
Vital signs
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
physical examination,
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
ADAs
Time frame: on the 22nd day after the last administration
Ctrough
Time frame: In two hours before the administration of the trial drug on the first day of the 1st, 3rd, 5th and 7th cycles, the 22nd day of the 8th cycle)/the 22nd day after the last administration. Each cycle was 21 days.
ECOG physical condition
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
left ventricular ejection fraction (LVEF),
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
adverse events (AE)
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
Individual participant dataSharing planned: Undecided

Related trials for HER2-positive Breast Cancer

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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HS022, Trastuzumab and Vinorelbine Bitartrate in people with HER2-positive Breast Cancer, run by Zhejiang Hisun Pharmaceutical Co. Ltd. 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 30 Oct 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: WEEK 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06107790.

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 30 Oct 2023.