Metastatic Breast CancerPhase 3NCT07008976
Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
A Phase 3 study testing TQB2102 Injection and Trastuzumab Emtansine for Injection in people with Metastatic Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 31 sites in China.
Trial summary
This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- TQB2102 Injection and Trastuzumab Emtansine for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 31 sitesChina
- Study dates
- 7 Jul 2025to Dec 2028
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Age: 18 - 75 years old (at the time of signing the informed consent form); Eastern Cooperative Oncology Group (ECOG )score ≤ 1; Expected survival period exceeds 3 months;
- HER2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination;
- According to the 2018 version of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP )HumanEpidermalGrowthFactorReceptor2 (HER2) testing guidelines, HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive;
- The hormone receptor (HR) status has been clearly determined:
- According to the 2020 version of the ASCO/CAP guidelines, HR positive includes ER positive and/or PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%.
Show all 10Show fewer
- Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage.
- Disease progression occurred during or after the most recent treatment or intolerance.
- At least 1 line of treatment has been received in the recurrence/metastasis stage.
- According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, at least one measurable lesion exists.
Who cannot join
- Excluded are patients with known spinal cord compression or active central nervous system metastases .
- Patients with only skin and/or intracranial lesions as target lesions.
- Patients with adverse reactions from previous treatments that have not recovered to a CTCAE v5.0 grade score of ≤1.
- Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- Patients with major cardiovascular diseases
- Patients with a history of interstitial lung disease/pneumonia (non-infectious type) requiring steroid intervention treatment, or currently having interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening period imaging and cannot be excluded.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
China31 sites, 31 recruiting
- Not yet recruiting
Anyang Cancer Hospital
Anyang, Henan, 455001
Junlan Guo, Master, 15037272967, fanyuguo201@163.com
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Shikai Wu, Doctor, 15810037303, skywu4923@sina.com
- Not yet recruiting
Beijing Shunyi Hospital
Beijing, Beijing Municipality, 101300
Bangwei Cao, Doctor, 13021161027, daweicao@163.com
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Bengbu, Anhui, 233099
Hui Zhang, Doctor, 18096503711, 14564014@qq.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Hongxia Cui, Master, 13504436090, 2503074283@qq.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Lihua Kang, Doctor, 13504334518, kanglihua961002@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yang Quchang Ou, Doctor, 139 7313 5318, ouyangquchang@hnca.org.cn
- Not yet recruiting
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024000
Yingqi Wu, Master, 18047660376, cfwyq2008@163.com
- Not yet recruiting
The Second Hospital Of Dalian Medical University
Dalian, Liaoning, 116000
Man Li, Doctor, 17709873580, iman126126@163.com
- Not yet recruiting
Dazhopu Central Hospital
Dazhou, Sichuan, 635000
Hongmei Song, Bachelor, 18982816012, shm0621@sina.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Chuangui Song, Doctor, 13960709993, songcg1971@outlook.com
- Not yet recruiting
Cancer Hospital Of Guizhou Medical University
Guiyang, Guizhou, 550001
Zhihong Wang, Master, 13595159308, wzh1968626@sina.com
- Not yet recruiting
Hainan General Hospital
Haikou, Hainan, 570311
Haixia Wang, Bachelor, 18907568536, Wanghaixia74@163.com
- Not yet recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002
Xinyu Qian, Doctor, 138 5715 4714, qianxinyu2008@163.com
- Not yet recruiting
Affiliated Cancer Hospital Of Harbin Medical University
Harbin, Heilongjiang, 150000
Qingyuan Zhang, Doctor, 13313612989, ns86298333@163.com
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Yueyin Pan, Doctor, 15395005376, yueyinpan1965@126.com
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Beicheng Sun, Doctor, 13776413940, peijing@ahmu.edu.cn
- Not yet recruiting
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
Jiamusi, Heilongjiang, 154007
Hongmei Sun, Master, 15344540000, SHM1357@163.com
- Not yet recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Xiaoping Li, Doctor, 18933183766, lixiaoping1983@126.com
- Not yet recruiting
Affiliated Hospital Of Jining Medical University
Jining, Shandong, 272029
Changping Shan, Bachelor, 18678766865, 18678766865@163.com
- Not yet recruiting
The First Hospital Of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoling Ling, Master, 18693165668, lingxiaolingedu@163.com
- Not yet recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276000
Guozhu Liu, Bachelor, 13605399906, liugz0929@163.com
- Not yet recruiting
The First Affiliated Hospital Of Henan University Of Science & Technology
Luoyang, Henan, 471000
Xinshuai Wang, Doctor, 13837986128, xshuaiw@126.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Zhengkui Sun, Doctor, 13907000210, sunzhengkui616@163.com
- Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Yan Gui, Master, 15882618827, 15882618827 15882618827@163.com
- Not yet recruiting
Affiliated Cancer Hospital Of Guangxi Medical University
Nanning, Guangxi, 530028
Aihua Tan, Doctor, 13877191963, tahanna@126.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Zhimin Shao, Doctor, 18017312288, szm@163.com
- Not yet recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110041
Tao Sun, Doctor, 18900917877, lnzlrxnsy@163.com
- Not yet recruiting
The Fourth Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050035
Li Ma, Doctor, 13932116886, mali1021@126.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jin Zhang, Doctor, 18622221173, zhangjintjmuch1@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Min Yan, Doctor, 15713857388, ym200678@126.com
About this study
Official title: A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer
This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
- Conditions
- Metastatic Breast Cancer
- Being tested
- TQB2102 Injection, Trastuzumab Emtansine for Injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 InjectionDrug
TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.
Trastuzumab Emtansine for InjectionDrug
Trastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 Injection | Experimental | The drug is administered by intravenous infusion, at a dose of 6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle. Receives: Drug: TQB2102 Injection |
| Trastuzumab Emtansine for Injection | Active comparator | The drug is administered by intravenous infusion, at a dose of 3.6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle. Receives: Drug: Trastuzumab Emtansine for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)
The PFS evaluation of TQB2102 for injection compared with Trastuzumab Emtansine for injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the Independent Imaging Review Committee (IRC).
Measured: Up 30 months
Secondary outcomes (11)
The PFS evaluated by the researchers
The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine in evaluating the progression-free survival (PFS) in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the researchers.
Measured: Up 30 months
The Overall Survival (OS) evaluated by the researchers
The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine, as evaluated by the researchers, in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs.
Measured: Up to 5 years
The Duration of Response (DOR) evaluated by the researchers
The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine as evaluated by the researchers in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was studied.
Measured: Up to 5 years
The Partial Response (PR) evaluated by the researchers
The efficacy of PR-assessed TQB2102 injection compared with Trastuzumab Emtansine injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was evaluated by the researchers.
Measured: Up to 5 years
The Objective Response Rate (ORR)evaluated by the researchers
The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine in evaluating the objective response rate (ORR) was assessed in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs.
Measured: Up to 5 years
The Clinical Benefit Rate (CBR) evaluated by the researchers
The efficacy of CBR evaluated injection TQB2102 compared to injection Trastuzumab Emtansine in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the researchers.
Measured: Up to 5 years
The incidence and severity of adverse events
The proportion of patients experiencing adverse events, and these adverse events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Sign the informed consent form, and until 28 days after the last medication administration / before starting a new anti-tumor treatment (which ever occurs first))
Antibody-drug conjugate (ADC)
Evaluate the population pharmacokinetic (PK) characteristics of TOB2102 for injection in patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs.
Measured: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
Total antibodies
Evaluate the population pharmacokinetic (PK) characteristics of TOB2102 for injection in patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs.
Measured: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
The small molecule toxin TO22723
The blood concentration of the small molecule toxin TO22723 in TOB2102.
Measured: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
The incidence rate of Anti-Drug Antibody (ADA)
Evaluate the immunogenicity of injectable TQB2102 in conditions such as ADA incidence rate. Subjects with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs.
Measured: Cycle 1, Cycle 2, Cycle 4, Cycle 8, Cycle 16, 28 days (±7 days) after the last administration (Each cycle is 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start7 Jul 2025
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008976
- Sponsor's protocol ID
- TQB2102-III-02
- Status last verified
- Apr 2025
- First submitted
- 30 May 2025
- Last updated
- 14 Aug 2025
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07008976
- Acronym / sponsor ID
- TQB2102-III-02
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jun 2025 (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 adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2102 Injection | Experimental | Drug: TQB2102 InjectionThe drug is administered by intravenous infusion, at a dose of 6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle. |
| Trastuzumab Emtansine for Injection | Active comparator | Drug: Trastuzumab Emtansine for InjectionThe drug is administered by intravenous infusion, at a dose of 3.6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Age: 18 - 75 years old (at the time of signing the informed consent form); Eastern Cooperative Oncology Group (ECOG )score ≤ 1; Expected survival period exceeds 3 months;
- HER2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination;
- According to the 2018 version of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP )HumanEpidermalGrowthFactorReceptor2 (HER2) testing guidelines, HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive;
- The hormone receptor (HR) status has been clearly determined:
Key exclusion criteria (6 listed)
- Excluded are patients with known spinal cord compression or active central nervous system metastases .
- Patients with only skin and/or intracranial lesions as target lesions.
- Patients with adverse reactions from previous treatments that have not recovered to a CTCAE v5.0 grade score of ≤1.
- Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- Patients with major cardiovascular diseases
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 |
|---|---|---|
| TQB2102 InjectionTQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate. | Drug | TQB2102 Injection |
| Trastuzumab Emtansine for InjectionTrastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC). | Drug | Trastuzumab Emtansine for Injection |
Primary outcome
The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)
Time frame: Up 30 months
The PFS evaluation of TQB2102 for injection compared with Trastuzumab Emtansine for injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the Independent Imaging Review Committee (IRC).
11 secondary outcomes
The PFS evaluated by the researchers
Time frame: Up 30 months
The Overall Survival (OS) evaluated by the researchers
Time frame: Up to 5 years
The Duration of Response (DOR) evaluated by the researchers
Time frame: Up to 5 years
The Partial Response (PR) evaluated by the researchers
Time frame: Up to 5 years
The Objective Response Rate (ORR)evaluated by the researchers
Time frame: Up to 5 years
The Clinical Benefit Rate (CBR) evaluated by the researchers
Time frame: Up to 5 years
The incidence and severity of adverse events
Time frame: Sign the informed consent form, and until 28 days after the last medication administration / before starting a new anti-tumor treatment (which ever occurs first))
Antibody-drug conjugate (ADC)
Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
Total antibodies
Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
The small molecule toxin TO22723
Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
The incidence rate of Anti-Drug Antibody (ADA)
Time frame: Cycle 1, Cycle 2, Cycle 4, Cycle 8, Cycle 16, 28 days (±7 days) after the last administration (Each cycle is 3 weeks)
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 14 Aug 2025.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2102 Injection and Trastuzumab Emtansine for Injection in people with Metastatic Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 31 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 10 inclusion and 6 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 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?
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 Zhimin Shao, Doctor (021-64175590, szm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC) (time frame: Up 30 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 14 Aug 2025.