Recurrent or Metastatic Breast CancerPhase 3NCT07406542
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
A Phase 3 study testing SYS6010 and Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) in people with Recurrent or Metastatic Breast Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first- or second-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Metastatic Breast Cancer
- What is being tested?
- SYS6010 and Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2030
- 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
- Age 18 to 75 years inclusive, no gender restrictions.
- Histopathologically confirmed breast cancer at an unresectable recurrent or metastatic stage, requiring: a) HER2-negative; b) EGFR-positive expression.
- Subjects must have received 1 to 2 lines of systemic chemotherapy regimens during the unresectable advanced or metastatic stage.
- At least one measurable lesion confirmed by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Brain metastases are evaluated only as non-target lesions. Patients with skin lesions only are ineligible.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected survival ≥3 months.
Show all 9Show fewer
- Adequate major organ function status within 7 days prior to first study drug administration.
- Subjects must agree to use effective contraception from informed consent signing until the protocol-specified time after last dose; females must not be lactating and males must refrain from sperm donation during this period. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first study drug administration. Female subjects must not be lactating.
- Voluntarily participate in this clinical study, understand the research procedures, and be able to sign a written informed consent form.
Who cannot join
- Presence of cancerous meningitis, spinal cord compression, or active central nervous system metastases. Active central nervous system metastases are specifically defined as untreated, symptomatic, or requiring corticosteroids/anticonvulsants to control related symptoms; except for cases stable for at least one month following treatment for brain metastases and having discontinued corticosteroids/anticonvulsants for >2 weeks.
- Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (including clinically significant recurrence requiring additional intervention within 2 weeks prior to enrollment).
- History of other malignancies within 3 years prior to first use of study drug, except for: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, and cervical carcinoma in situ
- Prior treatment with topoisomerase I inhibitors (including ADCs)
- Prior treatment with EGFR-targeted ADCs or monoclonal antibodies
- Known hypersensitivity to any component of SYS6010 or to humanized monoclonal antibody products
Show all 14Show fewer
- Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (excluding Grade 2 alopecia, asymptomatic laboratory abnormalities, etc., deemed safe by the investigator).
- Patients with inadequate washout periods for prior medications or treatments, as specified in the protocol, prior to the first administration of the study drug. 9. History of severe cardiovascular or cerebrovascular disease.
- 10. Clinically significant pulmonary impairment due to pulmonary complications. 11. History of interstitial lung disease (ILD)/non-infectious pneumonia requiring glucocorticoid therapy, current ILD/non-infectious pneumonia, or inability to exclude ILD/non-infectious pneumonia based on imaging at screening.
- 12. Subjects with active inflammatory bowel disease, gastrointestinal obstruction, active peptic ulcer, recent (within 4 weeks) gastrointestinal bleeding, gastrointestinal perforation, or severe gastrointestinal conditions such as abdominal abscess (excluding those with a history of resolved conditions).
- 13. Severe infection within 4 weeks prior to first use of the investigational drug, including but not limited to: bacteremia requiring hospitalization, severe pneumonia, active tuberculosis infection, or requiring oral or intravenous antibiotic, antifungal, or antiviral therapy due to infection within 2 weeks prior to first dosing (except for prophylactic use).
- 14. Uncontrolled diabetes (fasting blood glucose ≥10 mmol/L and/or HbA1c ≥8%). 15. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.
- 16. Human immunodeficiency virus (HIV) infection diagnosed as acquired immunodeficiency syndrome (AIDS).
- 17.Other conditions deemed unsuitable for participation in this clinical trial by the investigator (e.g., uncontrolled psychiatric disorders or anticipated poor compliance).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-Label, Parallel-Control, Multicenter Phase III Clinical Study of SYS6010 Versus Investigator's Choice Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first- or second-line chemotherapy. It aims to compare the efficacy and safety of SYS6010 monotherapy versus investigator-selected chemotherapy.The study plans to enroll approximately 400 subjects, randomly assigned in a 1:1 ratio to the treatment arm and control arm(Investigator's choice of standard chemotherapy regimen, including eribulin, capecitabine, gemcitabine, or vinorelbine).
Read the detailed description
This is a randomized, open-label, multicenter study designed to evaluate the efficacy and safety of SYS6010 injection versus investigator's choice of standard chemotherapy in patients with unresectable locally advanced or metastatic breast cancer that is HER2-negative with centrally confirmed EGFR expression, who have received at least one but no more than two prior lines of systemic chemotherapy for advanced or metastatic disease.
Approximately 400 patients will be enrolled and randomized in a 1:1 ratio to receive either SYS6010 injection or investigator's choice of chemotherapy. Patients randomized to the experimental arm will receive SYS6010 injection。 Patients randomized to the control arm will receive investigator's choice of standard chemotherapy, which may include eribulin, capecitabine, gemcitabine, or vinorelbine, administered per local label and institutional standard practice.
This study aims to determine whether SYS6010 provides clinically meaningful improvement in PFS compared with standard chemotherapy in patients with HER2-negative, EGFR-expressing advanced breast cancer.
The primary endpoint is progression-free survival (PFS) assessed by a blinded independent central review (BICR) per RECIST v1.1.
Secondary endpoints include overall survival (OS), investigator-assessed PFS, objective response rate (ORR), clinical benefit rate (CBR), disease control rate (DCR), duration of response (DoR), safety and tolerability, quality of life, pharmacokinetics, and immunogenicity.
- Conditions
- Recurrent or Metastatic Breast Cancer
- Being tested
- SYS6010, Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Medical subject headings
- Recurrence, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010Drug
SYS6010, intravenous infusion
Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)Drug
eribulin 1.4 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W Capecitabine 1000-1250 mg/m² orally Twice daily, Days 1-14, Q3W Gemcitabine 1000 mg/m² Intravenous infusion Administered on Days 1 and 8, Q3W Vinorelbine 25 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 | Experimental | Not described Receives: Drug: SYS6010 |
| Investigator's Choice of Chemotherapy | Active comparator | eribulin, capecitabine, gemcitabine, or vinorelbine Receives: Drug: Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS(progression free survival) assessed by BICR based on RECIST v1.1 criteria
Measured: Randomization up to approximately 36 months
Secondary outcomes (11)
OS (overall survival)
Overall survival is defined as the time from randomization to death from any cause.
Measured: Randomization up to approximately 60 months
Progression-Free Survival (PFS) Assessed by Investigator
Progression-free survival assessed by the investigator is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1.
Measured: Randomization up to approximately 36 months
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by both BICR and the investigator.
Measured: Randomization up to approximately 36 months.
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1, as assessed by both BICR and the investigato.
Measured: Randomization up to approximately 36 months.
Duration of Response (DoR)
Duration of response is defined as the time from the first documented evidence of complete response (CR) or partial response (PR) until the first documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1, as assessed by both BICR and the investigator.
Measured: Randomization up to approximately 36 months
Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Health-related quality of life will be assessed using the EORTC QLQ-C30 according to the Scoring Manual.
The EORTC QLQ-C30 consists of functional scales, symptom scales, and a Global Health Status/Quality of Life scale, with scores linearly transformed to a 0 to 100 scale.
For functional scales and the Global Health Status/Quality of Life scale, higher scores indicate better functioning or quality of life.
For symptom scales, higher scores indicate greater symptom burden. The outcome measure is the change from baseline in the selected QLQ-C30 scale scores at post-baseline assessments.
Measured: Randomization up to approximately 36 months
Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 42 (EORTC QLQ-BR42)
Breast cancer-specific quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR42), a supplementary module to the EORTC QLQ-C30, scored according to the EORTC QLQ-BR42 Scoring Manual.
Scores for each scale are linearly transformed to a 0 to 100 scale. For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
The outcome measure is the change from baseline in each BR42 scale score at post-baseline assessments.
Measured: Randomization up to approximately 36 months
AEs and SAEs
Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings.
Measured: From first dose of study treatment until 30 days after the last dose.
Maximum Observed Plasma Concentration (Cmax) of SYS6010
The maximum observed plasma concentration (Cmax) of SYS6010 will be determined based on measured plasma concentrations following study drug administration, using standard non-compartmental pharmacokinetic analysis methods.
Measured: Up to approximately 168 hours after the first dose of SYS6010.
Area Under the Plasma Concentration-Time Curve (AUC) of SYS6010
The area under the plasma concentration-time curve (AUC) of SYS6010 will be calculated based on measured plasma concentration-time data following study drug administration, using non-compartmental pharmacokinetic analysis.
Measured: From the first dose up to approximately 168 hours post-dose.
Number of Participants With Anti-Drug Antibodies (ADAs) to SYS6010
Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs) to SYS6010. Based on blood samples collected at predefined time points during the study.
Measured: From baseline (prior to first dose) up to approximately 30 days after the last dose of SYS6010.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical 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
- Model description
- multicenter, randomized, open-label, parallel-control Phase III clinical trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406542
- Sponsor's protocol ID
- SYS6010-021
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 12 Feb 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Control, Multicenter Phase III Clinical Study of SYS6010 Versus Investigator's Choice Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07406542
- Acronym / sponsor ID
- SYS6010-021
- Conditions
- Recurrent or Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 12 Feb 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 is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first- or second-line chemotherapy. It aims to compare the efficacy and safety of SYS6010 monotherapy versus investigator-selected chemotherapy.The study plans to enroll approximately 400 subjects, randomly assigned in a 1:1 ratio to the treatment arm and control arm(Investigator's choice of standard chemotherapy regimen, including eribulin, capecitabine, gemcitabine, or vinorelbine).
Detailed description
This is a randomized, open-label, multicenter study designed to evaluate the efficacy and safety of SYS6010 injection versus investigator's choice of standard chemotherapy in patients with unresectable locally advanced or metastatic breast cancer that is HER2-negative with centrally confirmed EGFR expression, who have received at least one but no more than two prior lines of systemic chemotherapy for advanced or metastatic disease.
Approximately 400 patients will be enrolled and randomized in a 1:1 ratio to receive either SYS6010 injection or investigator's choice of chemotherapy. Patients randomized to the experimental arm will receive SYS6010 injection。 Patients randomized to the control arm will receive investigator's choice of standard chemotherapy, which may include eribulin, capecitabine, gemcitabine, or vinorelbine, administered per local label and institutional standard practice.
This study aims to determine whether SYS6010 provides clinically meaningful improvement in PFS compared with standard chemotherapy in patients with HER2-negative, EGFR-expressing advanced breast cancer.
The primary endpoint is progression-free survival (PFS) assessed by a blinded independent central review (BICR) per RECIST v1.1.
Secondary endpoints include overall survival (OS), investigator-assessed PFS, objective response rate (ORR), clinical benefit rate (CBR), disease control rate (DCR), duration of response (DoR), safety and tolerability, quality of life, pharmacokinetics, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, randomized, open-label, parallel-control Phase III clinical trial
| Arm | Type | Receives |
|---|---|---|
| SYS6010 | Experimental | Drug: SYS6010 |
| Investigator's Choice of Chemotherapy | Active comparator | Drug: Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)eribulin, capecitabine, gemcitabine, or vinorelbine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 75 years inclusive, no gender restrictions.
- Histopathologically confirmed breast cancer at an unresectable recurrent or metastatic stage, requiring: a) HER2-negative; b) EGFR-positive expression.
- Subjects must have received 1 to 2 lines of systemic chemotherapy regimens during the unresectable advanced or metastatic stage.
- At least one measurable lesion confirmed by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Brain metastases are evaluated only as non-target lesions. Patients with skin lesions only are ineligible.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Key exclusion criteria (14 listed)
- Presence of cancerous meningitis, spinal cord compression, or active central nervous system metastases. Active central nervous system metastases are specifically defined as untreated, symptomatic, or requiring corticosteroids/anticonvulsants to control related symptoms; except for cases stable for at least one month following treatment for brain metastases and having discontinued corticosteroids/anticonvulsants for >2 weeks.
- Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (including clinically significant recurrence requiring additional intervention within 2 weeks prior to enrollment).
- History of other malignancies within 3 years prior to first use of study drug, except for: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, and cervical carcinoma in situ
- Prior treatment with topoisomerase I inhibitors (including ADCs)
- Prior treatment with EGFR-targeted ADCs or monoclonal antibodies
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 |
|---|---|---|
| SYS6010SYS6010, intravenous infusion | Drug | SYS6010 |
| Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)eribulin 1.4 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W Capecitabine 1000-1250 mg/m² orally Twice daily, Days 1-14, Q3W Gemcitabine 1000 mg/m² Intravenous infusion Administered on Days 1 and 8, Q3W Vinorelbine 25 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W | Drug | Investigator's Choice of Chemotherapy |
Primary outcome
PFS
Time frame: Randomization up to approximately 36 months
PFS(progression free survival) assessed by BICR based on RECIST v1.1 criteria
11 secondary outcomes
OS (overall survival)
Time frame: Randomization up to approximately 60 months
Progression-Free Survival (PFS) Assessed by Investigator
Time frame: Randomization up to approximately 36 months
Objective Response Rate (ORR)
Time frame: Randomization up to approximately 36 months.
Disease Control Rate (DCR)
Time frame: Randomization up to approximately 36 months.
Duration of Response (DoR)
Time frame: Randomization up to approximately 36 months
Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Randomization up to approximately 36 months
Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 42 (EORTC QLQ-BR42)
Time frame: Randomization up to approximately 36 months
AEs and SAEs
Time frame: From first dose of study treatment until 30 days after the last dose.
Maximum Observed Plasma Concentration (Cmax) of SYS6010
Time frame: Up to approximately 168 hours after the first dose of SYS6010.
Area Under the Plasma Concentration-Time Curve (AUC) of SYS6010
Time frame: From the first dose up to approximately 168 hours post-dose.
Number of Participants With Anti-Drug Antibodies (ADAs) to SYS6010
Time frame: From baseline (prior to first dose) up to approximately 30 days after the last dose of SYS6010.
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 12 Feb 2026.
Related trials for Recurrent or Metastatic Breast Cancer
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 2
A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
Triple-negative Breast Cancer
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Active, not recruitingPhase 2
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Carcinoma, Metastatic 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYS6010 and Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) in people with Recurrent or Metastatic Breast Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Randomization up to approximately 36 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 12 Feb 2026.