Triple-Negative Breast Cancer (TNBC)Phase 2NCT07752550
Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer
A Phase 2 study testing Retlirafusp alfa+Nab-paclitaxel:, Retlirafusp alfa+Fluzoparib and Retlirafusp alfa+TP-AC in people with Triple-Negative Breast Cancer (TNBC), run by Harbin Medical University at 1 site in China.
Trial summary
To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- Retlirafusp alfa+Nab-paclitaxel:, Retlirafusp alfa+Fluzoparib and Retlirafusp alfa+TP-AC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Jul 2029
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, female;
- Histopathologically confirmed recurrent or metastatic triple-negative breast cancer, defined as ER-negative (IHC ER-positive percentage <1%), PR-negative (IHC PR-positive percentage <1%), and HER2-negative (IHC -/+ or IHC ++ but FISH/CISH -);
- At least one measurable lesion per RECIST version 1.1 criteria;
- Advanced cohort:
- Metastatic or unresectable locally advanced TNBC (no prior systemic therapy or completed neoadjuvant/adjuvant therapy ≥12 months); PD-L1 positive with a Combined Positive Score (CPS) ≥1;
- Neoadjuvant cohort:
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- Clinical stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) previously untreated breast cancer patients;
- Life expectancy ≥3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Available tissue sample for testing, and gBRCA1/2 mutation status must be determined prior to treatment;
- Adequate major organ function meeting the following criteria (no blood transfusion or use of granulocyte colony-stimulating factor or thrombopoietin within 2 weeks prior to screening):
- Hematologic: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥90×10⁹/L; hemoglobin (Hb) ≥90 g/L; Biochemical: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤1.5× ULN (≤3× ULN for patients with liver metastases); alkaline phosphatase ≤2.5× ULN; BUN and creatinine ≤1.5× ULN with creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula); Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should also be assessed; patients with normal T3 and T4 levels may be enrolled); Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%; 18-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) <480 ms for females;
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use adequate contraception during the study period and for at least 4 months after the last dose of study drug;
- Willing to participate, capable of providing signed informed consent, and compliant with study procedures.
Who cannot join
- Concurrently receiving anti-tumor therapy in another clinical trial;
- Received other anti-tumor therapy within 4 weeks prior to the first dose of study drug;
- Prior treatment with tumor immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 inhibitors, etc.) or TGF-β inhibitors;
- Prior treatment with PARP inhibitors (except for patients who completed PARP inhibitor therapy for ovarian cancer ≥5 years ago with no recurrence or metastasis);
- Untreated active brain metastases or leptomeningeal metastases;
- Underwent major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or have not fully recovered from such surgery;
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- Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); patients with vitiligo or childhood asthma that has completely resolved and does not require any intervention in adulthood may be included; patients with asthma requiring bronchodilator therapy for medical intervention are excluded;
- Severe cardiac disease or conditions, including but not limited to: documented history of heart failure or systolic dysfunction (LVEF <50%); uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree or third-degree atrioventricular block); angina requiring anti-anginal medication; clinically significant valvular heart disease; ECG showing transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg);
- Congenital or acquired immunodeficiency (e.g., HIV-infected patients);
- Received live vaccine within 4 weeks prior to study drug administration or likely to receive such vaccine during the study period;
- Known hypersensitivity to any component of the study drugs in this protocol;
- Severe concomitant disease or other comorbidities that may interfere with the planned treatment, or any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.
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
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
About this study
Official title: Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer: An Exploratory Clinical Study
To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.
Read the detailed description
Triple-negative breast cancer (TNBC) is the molecular subtype with the poorest prognosis among breast cancers, characterized by high rates of early recurrence, rapid distant metastasis, and short overall survival. Due to the lack of estrogen receptor, progesterone receptor, and HER2 expression, TNBC is insensitive to endocrine therapy and targeted therapy, making chemotherapy the mainstay of systemic treatment for a long time. However, conventional chemotherapy offers limited efficacy, and treatment options become scarce after the development of drug resistance. In recent years, immune checkpoint inhibitors have shown promising prospects in TNBC, particularly in PD-L1-positive patients who may benefit from immunotherapy combined with chemotherapy; nevertheless, a substantial proportion of patients still fail to achieve durable responses. In addition, PARP inhibitors have provided a new therapeutic option for TNBC patients harboring gBRCA mutations, and they exhibit potential synergistic effects with immunotherapy. Retlirafusp alfa (SHR-1701) is a domestically developed bifunctional fusion protein targeting PD-L1 and TGF-β, which can simultaneously block the PD-1/PD-L1 pathway and neutralize TGF-β in the tumor microenvironment, thereby enhancing anti-tumor immune responses. It has demonstrated promising efficacy and manageable safety in tumor types such as gastric cancer. Based on the above background, this study aims to explore the efficacy and safety of Retlirafusp alfa combined with chemotherapy or fluzoparib in early-stage and advanced TNBC, in order to provide novel therapeutic strategies for TNBC patients.
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- Retlirafusp alfa+Nab-paclitaxel:, Retlirafusp alfa+Fluzoparib, Retlirafusp alfa+TP-AC
- Keywords
- Triple-negative breast cancer, Retlirafusp alfa, Fluzoparib
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retlirafusp alfa+Nab-paclitaxel:Drug
Retlirafusp alfa+Nab-paclitaxel
Retlirafusp alfa+FluzoparibDrug
Retlirafusp alfa+Fluzoparib
Retlirafusp alfa+TP-ACDrug
Retlirafusp alfa+TP-AC
Retlirafusp alfa+FluzoparibDrug
Retlirafusp alfa+Fluzoparib
| Study group | Role | What they receive |
|---|---|---|
| Advanced cohort: gBRCA1/2 wild-type | Experimental | Retlirafusp alfa + nab-paclitaxel Receives: Drug: Retlirafusp alfa+Nab-paclitaxel: |
| Advanced cohort: gBRCA1/2 pathogenic or likely pathogenic mutation | Experimental | Retlirafusp alfa + fluzoparib Receives: Drug: Retlirafusp alfa+Fluzoparib |
| Early neoadjuvant cohort: gBRCA1/2 wild-type | Experimental | Retlirafusp alfa+TP-AC Receives: Drug: Retlirafusp alfa+TP-AC |
| Early neoadjuvant cohort: gBRCA1/2 pathogenic or likely pathogenic mutation | Experimental | Retlirafusp alfa+ Fluzoparib Receives: Drug: Retlirafusp alfa+Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late-Stage Cohort-Objective Response Rate
Proportion of patients with best overall response of complete response (CR) or partial response (PR) from treatment initiation to disease progression.
Measured: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Neoadjuvant Cohort-tpCR (ypT0/is ypN0)
Pathologic complete response with no residual invasive carcinoma in breast and ipsilateral lymph nodes after neoadjuvant therapy and surgery.
Measured: Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.
Secondary outcomes (11)
Late-Stage Cohort-Disease Control Rate
Proportion of patients with best overall response of CR, PR, or stable disease (SD) from treatment initiation to disease progression.
Measured: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Late-Stage Cohort-Clinical Benefit Rate
Proportion of patients with confirmed CR, PR, or SD lasting ≥24 weeks.
Measured: Assessed until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Late-Stage Cohort-Progression-Free Survival
Time from treatment initiation to first radiographic disease progression or death from any cause.
Measured: Assessed every 3 months during treatment and follow-up until disease progression, death, or start of subsequent anticancer therapy. Analysis cutoff at 36 months.
Late-Stage Cohort-Overall Survival
Time from treatment initiation to death from any cause.
Measured: Follow-up every 3 months via clinic visit or telephone call after treatment completion until death or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-bpCR (ypT0/is)
Pathologic complete response with no residual invasive carcinoma in breast (lymph node status disregarded) after neoadjuvant therapy and surgery.
Measured: Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.
Neoadjuvant Cohort-Objective Response Rate
Proportion of patients with best overall response of CR or PR during neoadjuvant therapy.
Measured: Assessed every 6 weeks (every 2 cycles) during neoadjuvant therapy until treatment completion. Analysis cutoff at 6 months.
Neoadjuvant Cohort-Event-Free Survival
Time from treatment initiation to first occurrence of preoperative disease progression, postoperative recurrence, or death from any cause.
Measured: Follow-up every 3 months from treatment start until event or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-Disease-Free Survival
Time from surgery to first postoperative recurrence or death from any cause.
Measured: Follow-up every 3 months from surgery until recurrence, death, or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-Distant Disease-Free Survival
Time from surgery to first distant metastasis or death from any cause.
Measured: Follow-up every 3 months from surgery until distant metastasis, death, or study end. Analysis cutoff at 36 months.
Adverse Event (AE) Incidence
Incidence, severity, and drug-relatedness of AEs and SAEs, graded per NCI-CTCAE v6.0.
Measured: Recorded from informed consent signing through 30 days after last dose (SAEs and immune-related AEs through 90 days after last dose); maximum follow-up of 36 months.
Biomarker Exploration
Collection of tumor tissue and peripheral blood samples to analyze potential biomarkers associated with efficacy, resistance, and safety.
Measured: Blood samples collected at baseline, Cycle 5 Day 1, and Cycle 8 Day 1 (21-day cycle); tumor tissue collected at baseline from archived FFPE blocks or fresh biopsy. Analysis cutoff at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tong Liu, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752550
- Sponsor's protocol ID
- MA-BC-II-146
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer: An Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT07752550
- Acronym / sponsor ID
- MA-BC-II-146
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Keywords
- Triple-negative breast cancer, Retlirafusp alfa, Fluzoparib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 7 Aug 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.
To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.
Detailed description
Triple-negative breast cancer (TNBC) is the molecular subtype with the poorest prognosis among breast cancers, characterized by high rates of early recurrence, rapid distant metastasis, and short overall survival. Due to the lack of estrogen receptor, progesterone receptor, and HER2 expression, TNBC is insensitive to endocrine therapy and targeted therapy, making chemotherapy the mainstay of systemic treatment for a long time. However, conventional chemotherapy offers limited efficacy, and treatment options become scarce after the development of drug resistance. In recent years, immune checkpoint inhibitors have shown promising prospects in TNBC, particularly in PD-L1-positive patients who may benefit from immunotherapy combined with chemotherapy; nevertheless, a substantial proportion of patients still fail to achieve durable responses. In addition, PARP inhibitors have provided a new therapeutic option for TNBC patients harboring gBRCA mutations, and they exhibit potential synergistic effects with immunotherapy. Retlirafusp alfa (SHR-1701) is a domestically developed bifunctional fusion protein targeting PD-L1 and TGF-β, which can simultaneously block the PD-1/PD-L1 pathway and neutralize TGF-β in the tumor microenvironment, thereby enhancing anti-tumor immune responses. It has demonstrated promising efficacy and manageable safety in tumor types such as gastric cancer. Based on the above background, this study aims to explore the efficacy and safety of Retlirafusp alfa combined with chemotherapy or fluzoparib in early-stage and advanced TNBC, in order to provide novel therapeutic strategies for TNBC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Advanced cohort: gBRCA1/2 wild-type | Experimental | Drug: Retlirafusp alfa+Nab-paclitaxel:Retlirafusp alfa + nab-paclitaxel |
| Advanced cohort: gBRCA1/2 pathogenic or likely pathogenic mutation | Experimental | Drug: Retlirafusp alfa+FluzoparibRetlirafusp alfa + fluzoparib |
| Early neoadjuvant cohort: gBRCA1/2 wild-type | Experimental | Drug: Retlirafusp alfa+TP-ACRetlirafusp alfa+TP-AC |
| Early neoadjuvant cohort: gBRCA1/2 pathogenic or likely pathogenic mutation | Experimental | Drug: Retlirafusp alfa+FluzoparibRetlirafusp alfa+ Fluzoparib |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years, female;
- Histopathologically confirmed recurrent or metastatic triple-negative breast cancer, defined as ER-negative (IHC ER-positive percentage <1%), PR-negative (IHC PR-positive percentage <1%), and HER2-negative (IHC -/+ or IHC ++ but FISH/CISH -);
- At least one measurable lesion per RECIST version 1.1 criteria;
- Advanced cohort:
- Metastatic or unresectable locally advanced TNBC (no prior systemic therapy or completed neoadjuvant/adjuvant therapy ≥12 months); PD-L1 positive with a Combined Positive Score (CPS) ≥1;
Key exclusion criteria (12 listed)
- Concurrently receiving anti-tumor therapy in another clinical trial;
- Received other anti-tumor therapy within 4 weeks prior to the first dose of study drug;
- Prior treatment with tumor immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 inhibitors, etc.) or TGF-β inhibitors;
- Prior treatment with PARP inhibitors (except for patients who completed PARP inhibitor therapy for ovarian cancer ≥5 years ago with no recurrence or metastasis);
- Untreated active brain metastases or leptomeningeal metastases;
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 |
|---|---|---|
| Retlirafusp alfa+Nab-paclitaxel:Retlirafusp alfa+Nab-paclitaxel | Drug | Advanced cohort: gBRCA1/2 wild-type |
| Retlirafusp alfa+FluzoparibRetlirafusp alfa+Fluzoparib | Drug | Advanced cohort: gBRCA1/2 pathogenic or likely pathogenic mutation |
| Retlirafusp alfa+TP-ACRetlirafusp alfa+TP-AC | Drug | Early neoadjuvant cohort: gBRCA1/2 wild-type |
| Retlirafusp alfa+FluzoparibRetlirafusp alfa+Fluzoparib | Drug | Early neoadjuvant cohort: gBRCA1/2 pathogenic or likely pathogenic mutation |
Primary outcome
Late-Stage Cohort-Objective Response Rate
Time frame: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Proportion of patients with best overall response of complete response (CR) or partial response (PR) from treatment initiation to disease progression.
Neoadjuvant Cohort-tpCR (ypT0/is ypN0)
Time frame: Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.
Pathologic complete response with no residual invasive carcinoma in breast and ipsilateral lymph nodes after neoadjuvant therapy and surgery.
11 secondary outcomes
Late-Stage Cohort-Disease Control Rate
Time frame: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Late-Stage Cohort-Clinical Benefit Rate
Time frame: Assessed until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Late-Stage Cohort-Progression-Free Survival
Time frame: Assessed every 3 months during treatment and follow-up until disease progression, death, or start of subsequent anticancer therapy. Analysis cutoff at 36 months.
Late-Stage Cohort-Overall Survival
Time frame: Follow-up every 3 months via clinic visit or telephone call after treatment completion until death or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-bpCR (ypT0/is)
Time frame: Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.
Neoadjuvant Cohort-Objective Response Rate
Time frame: Assessed every 6 weeks (every 2 cycles) during neoadjuvant therapy until treatment completion. Analysis cutoff at 6 months.
Neoadjuvant Cohort-Event-Free Survival
Time frame: Follow-up every 3 months from treatment start until event or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-Disease-Free Survival
Time frame: Follow-up every 3 months from surgery until recurrence, death, or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-Distant Disease-Free Survival
Time frame: Follow-up every 3 months from surgery until distant metastasis, death, or study end. Analysis cutoff at 36 months.
Adverse Event (AE) Incidence
Time frame: Recorded from informed consent signing through 30 days after last dose (SAEs and immune-related AEs through 90 days after last dose); maximum follow-up of 36 months.
Biomarker Exploration
Time frame: Blood samples collected at baseline, Cycle 5 Day 1, and Cycle 8 Day 1 (21-day cycle); tumor tissue collected at baseline from archived FFPE blocks or fresh biopsy. Analysis cutoff at 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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 Retlirafusp alfa+Nab-paclitaxel:, Retlirafusp alfa+Fluzoparib and Retlirafusp alfa+TP-AC in people with Triple-Negative Breast Cancer (TNBC), run by Harbin Medical University 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 14 inclusion and 12 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 7 Aug 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 Tong Liu, M.D. (+8615945953777, liutong@hrbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late-Stage Cohort-Objective Response Rate (time frame: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.). The study lists 2 primary outcomes in all. 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 7 Aug 2026.