SarcomaPhase 2MAGNATE-SNCT07359053
MAGNATE-S: Paclitaxel Polymer Micelles Combo in Advanced Sarcoma
A Phase 2 study testing Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib and Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib in people with Sarcoma, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
What is this study about? This is a medical research study testing a new drug combination ("Paclitaxel Polymer Micelles" + "Gemcitabine" + "Targeted Therapy") for patients with locally advanced unresectable or metastatic bone and soft tissue sarcomas whose disease has progressed after first-line standard therapy. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib and Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed Consent: The subject has signed the informed consent form after receiving and understanding full explanation regarding the trial's purpose, procedures, anticipated efficacy, pharmacological actions, and risks.
- Target Population:
- Histologically confirmed advanced/metastatic bone or soft tissue sarcoma. (If recurrence or metastasis is not definitive, a biopsy with frozen section is recommended. Enrollment may proceed if frozen pathology suggests recurrence/metastasis.)
- At least one measurable lesion per RECIST 1.1 criteria.
- Disease progression after prior first-line standard chemotherapy; ECOG performance status 0-2.
- Life expectancy ≥ 3 months.
Show all 19Show fewer
- Willing and able to comply with study procedures, treatment, and follow-up.
- No contraindications to paclitaxel polymer micelles, gemcitabine, or small-molecule anti-angiogenic targeted agents.
- Physical Examination and Laboratory Results:
- Adequate hematologic function: i) Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L; ii) Platelet count ≥ 100 × 10⁹/L; iii) Hemoglobin ≥ 90 g/L. (If transfusions are given during screening, a repeat test after 1 week must meet these criteria.)
- Adequate hepatic function: i) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ii) AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present); Alkaline phosphatase (ALP) ≤ 5 × ULN (liver mets) or ≤ 10 × ULN (bone mets).
- Adequate renal function: Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 50 mL/min.
- Adequate coagulation: INR ≤ 1.5 × ULN and PT/aPTT ≤ 1.5 × ULN, unless on stable anticoagulant therapy.
- Hepatitis B: Subjects positive for HBsAg are eligible if, in the investigator's judgment, their chronic hepatitis B is stable and does not increase the subject's risk.
- Cardiac Function: No symptomatic cardiac insufficiency at baseline (NYHA class ≤ II) and no clinically significant ECG abnormalities.
- Age and Reproductive Status:
- Aged 12-70 years (male and female).
- Subjects of childbearing potential must agree to use effective contraception during the trial. A negative serum or urine pregnancy test within 24 hours before chemotherapy is required for women of childbearing potential.
- Female subjects must not be breastfeeding.
Who cannot join
- Known allergy or intolerance to any component or excipient of the investigational products.
- Primary brain tumor or central nervous system (CNS) metastases (including leptomeningeal metastases), except for a single, well-controlled, asymptomatic brain metastasis. CNS tumors still presenting with increased intracranial pressure or neuropsychiatric symptoms after treatment.
- Uncontrolled acute or chronic infections, or other severe concurrent medical conditions.
- History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Active hepatitis or hepatic tumor burden exceeding 50% of the total liver volume.
- Uncontrolled third-space fluid accumulation not manageable by drainage (e.g., moderate to large pleural effusion, pericardial effusion, or ascites). Minimal asymptomatic fluid not requiring intervention may be allowed upon strict review.
Show all 17Show fewer
- Psychiatric illness or cognitive impairment leading to poor compliance or inability to cooperate and report treatment responses.
- Severe organic disease or major organ failure (e.g., decompensated heart or lung failure) precluding tolerance to chemotherapy.
- Coagulopathy (INR >1.5, APTT >1.5 × ULN), bleeding tendency (e.g., active gastric ulcer, stool occult blood [++], hematemesis and/or melena within the past 3 months, hemoptysis), or tumor proximity to major blood vessels.
- Coronary artery disease above grade I, arrhythmia (including QTc interval >450 ms for males, >470 ms for females), use of antiarrhythmic medication, or relevant underlying cardiac disease/cardiac insufficiency.
- Renal insufficiency, history of renal disease, or proteinuria (urine protein ≥2+ or 24-hour urine protein >1.0 g).
- History of organ transplantation.
- History of substance abuse, chronic alcoholism, or infectious diseases such as AIDS.
- Long-term use of corticosteroids or immunosuppressants.
- Vaccination with live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, oral typhoid) within 4 weeks prior to enrollment, or planned vaccination during the study. COVID-19 vaccination is permitted.
- Active hepatitis B (HBV DNA ≥1×10⁴ copies/mL or ≥2000 IU/mL) or hepatitis C (HCV RNA ≥15 IU/mL) infection; positive HIV antibody (unless clinically indicated); or positive syphilis antibody (TPPA).
- Any other condition deemed by the investigator to prevent completion of the trial or render the subject unsuitable (e.g., tumors like GIST or ALK-mutant inflammatory myofibroblastic tumor unsuitable for this chemotherapy regimen).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth Peolple'S Hospital
Shanghai, CH, 200233
Chenliang Zhou, MD, 18930170437, billzcl@msn.cn
About this study
Official title: MAGNATE-S: A Phase 2 Exploratory Study of Paclitaxel Polymer Micelles Combined With Gemcitabine and Anti-Angiogenic TKIs (Lenvatinib or Anlotinib) for Advanced Bone and Soft Tissue Sarcomas
What is this study about? This is a medical research study testing a new drug combination ("Paclitaxel Polymer Micelles" + "Gemcitabine" + "Targeted Therapy") for patients with locally advanced unresectable or metastatic bone and soft tissue sarcomas whose disease has progressed after first-line standard therapy. Currently, there is a lack of highly effective subsequent treatment options for these patients.
Why is this study being done? To improve efficacy: the investigators hope this drug combination can control tumor growth more effectively than current treatments.
Read more
To reduce toxicity: The "Paclitaxel Polymer Micelles" used in the study is a new formulation that may be safer than traditional paclitaxel, with a lower risk of severe allergic reactions.
For precise treatment: the investigators will select different targeted drugs (Lenvatinib for bone sarcoma or Anlotinib for soft tissue sarcoma) based on the tumor type, aiming for more tailored therapy.
How will the study be conducted?
Design: This is an exploratory study, planning to enroll approximately 46 patients in total, divided into two separate groups (23 for bone sarcoma, 23 for soft tissue sarcoma).
Process: Eligible and consenting patients will receive periodic combined drug therapy. Doctors will regularly evaluate efficacy and monitor safety through blood tests, US, CT, or MRI scans.
Primary Goal: The main focus is to see how many patients experience significant tumor shrinkage (Objective Response Rate), and to record all adverse reactions that occur.
Biomarker Research: To better understand treatment mechanisms and identify potential predictive markers, this study includes the collection of biological samples for future research, with careful design to minimize additional burden. Small extra blood samples will be collected during scheduled routine blood draws required for clinical monitoring. If a tumor biopsy or surgery is performed as part of necessary clinical care, the investigators will request permission to preserve a portion of the remaining tissue that would otherwise be discarded. These samples may be analyzed using techniques such as genetic or protein testing.
What does this mean for participants?
Potential Benefits: Participants have the opportunity to receive the new drug "Paclitaxel Polymer Micelles" free of charge and may benefit from it. Their participation will provide valuable treatment experience for all future patients with similar conditions.
Potential Risks: The drug combination may increase the risk of certain side effects, such as fatigue, nausea, high blood pressure, hand-foot skin reactions, or decreased blood cell counts. The research team has developed detailed plans to prevent and manage these situations.
Voluntary Principle: Participation is completely voluntary. Patients have the right to withdraw from the study at any time, for any reason, without affecting their right to receive other routine medical care.
In summary, this study explores a regimen combining a novel nano-drug, chemotherapy, and precise targeted therapy, aiming to find a more effective and safer treatment option for patients with advanced bone and soft tissue sarcomas who have failed first-line treatment.
- Conditions
- Sarcoma
- Being tested
- Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib, Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib
- Keywords
- advanced sarcoma, Paclitaxel Polymer Micelles
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Polymer Micelles + Gemcitabine + LenvatinibDrug
- Paclitaxel Polymer Micelles + Gemcitabine: Paclitaxel Micelles: 230 mg/m² (C1), then 300 mg/m² if tolerated, IV (≥3h), D8, Q3W. Gemcitabine: 800 mg/m², IV (90min), D1\&D8, Q3W. Planned for 6 cycles, may extend >6 cycles (based on investigator assessment of continued clinical benefit and patient tolerance) with patient self-pay for Paclitaxel Micelles.
- Lenvatinib (Bone Sarcoma): 12-16 mg daily (8-12 mg if <60 kg), continuous oral dosing until progression.
General Rules: Dose adjustments based on CTCAE v5.0. For patients with systemic benefit (PR/SD per RECIST 1.1 for ≥2 cycles), localized interventions (e.g., surgery, radiation) are permitted following MDT evaluation and with protocol-defined study drug adjustments.
Paclitaxel Polymer Micelles + Gemcitabine + AnlotinibDrug
- Paclitaxel Polymer Micelles + Gemcitabine: Paclitaxel Micelles: 230 mg/m² (C1), then 300 mg/m² if tolerated, IV (≥3h), D8, Q3W. Gemcitabine: 800 mg/m², IV (90min), D1\&D8, Q3W. Planned for 6 cycles, may extend >6 cycles (based on investigator assessment of continued clinical benefit and patient tolerance) with patient self-pay for Paclitaxel Micelles.
- Anlotinib (Soft Tissue Sarcoma): 12 mg daily (8 mg if <45 kg), oral (2 wks on/1 wk off) until progression.
General Rules: Dose adjustments based on CTCAE v5.0. For patients with systemic benefit (PR/SD per RECIST 1.1 for ≥2 cycles), localized interventions (e.g., surgery, radiation) are permitted following MDT evaluation and with protocol-defined study drug adjustments.
| Study group | Role | What they receive |
|---|---|---|
| bone sarcoma | Experimental | Not described Receives: Drug: Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib |
| soft tissue sarcoma | Experimental | Not described Receives: Drug: Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: assessed up to 1 year
Secondary outcomes (5)
Progression-Free-Survival
Measured: assessed up to 1 year
Disease Control Rate
Measured: assessed up to 1 year
Duration of Response
Measured: assessed up to 1 year
Time To Progression
Measured: assessed up to 1 year
Incidence of adverse events
Measured: assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start25 Dec 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Zan, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359053
- Sponsor's protocol ID
- 2025-206
- Other IDs
- 2025-206
- Acronym
- MAGNATE-S
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary publication of this trial (including de-identified demographic, clinical, efficacy, and safety data), the study protocol, statistical analysis plan, and informed consent form will be made available. Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal that has been approved by an independent review committee. Proposals should be directed to the corresponding author. Time Frame: Data will become available 12 months after the primary results publication and will remain accessible for 5 years. Mechanism: Data will be provided in a secure, de-identified format via a trusted data repository or upon direct request, subject to a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAGNATE-S: A Phase 2 Exploratory Study of Paclitaxel Polymer Micelles Combined With Gemcitabine and Anti-Angiogenic TKIs (Lenvatinib or Anlotinib) for Advanced Bone and Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT07359053
- Acronym / sponsor ID
- MAGNATE-S / 2025-206
- Conditions
- Sarcoma
- Keywords
- advanced sarcoma, Paclitaxel Polymer Micelles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What is this study about? This is a medical research study testing a new drug combination ("Paclitaxel Polymer Micelles" + "Gemcitabine" + "Targeted Therapy") for patients with locally advanced unresectable or metastatic bone and soft tissue sarcomas whose disease has progressed after first-line standard therapy. Currently, there is a lack of highly effective subsequent treatment options for these patients.
Why is this study being done? To improve efficacy: the investigators hope this drug combination can control tumor growth more effectively than current treatments.
To reduce toxicity: The "Paclitaxel Polymer Micelles" used in the study is a new formulation that may be safer than traditional paclitaxel, with a lower risk of severe allergic reactions.
For precise treatment: the investigators will select different targeted drugs (Lenvatinib for bone sarcoma or Anlotinib for soft tissue sarcoma) based on the tumor type, aiming for more tailored therapy.
How will the study be conducted?
Design: This is an exploratory study, planning to enroll approximately 46 patients in total, divided into two separate groups (23 for bone sarcoma, 23 for soft tissue sarcoma).
Process: Eligible and consenting patients will receive periodic combined drug therapy. Doctors will regularly evaluate efficacy and monitor safety through blood tests, US, CT, or MRI scans.
Primary Goal: The main focus is to see how many patients experience significant tumor shrinkage (Objective Response Rate), and to record all adverse reactions that occur.
Biomarker Research: To better understand treatment mechanisms and identify potential predictive markers, this study includes the collection of biological samples for future research, with careful design to minimize additional burden. Small extra blood samples will be collected during scheduled routine blood draws required for clinical monitoring. If a tumor biopsy or surgery is performed as part of necessary clinical care, the investigators will request permission to preserve a portion of the remaining tissue that would otherwise be discarded. These samples may be analyzed using techniques such as genetic or protein testing.
What does this mean for participants?
Potential Benefits: Participants have the opportunity to receive the new drug "Paclitaxel Polymer Micelles" free of charge and may benefit from it. Their participation will provide valuable treatment experience for all future patients with similar conditions.
Potential Risks: The drug combination may increase the risk of certain side effects, such as fatigue, nausea, high blood pressure, hand-foot skin reactions, or decreased blood cell counts. The research team has developed detailed plans to prevent and manage these situations.
Voluntary Principle: Participation is completely voluntary. Patients have the right to withdraw from the study at any time, for any reason, without affecting their right to receive other routine medical care.
In summary, this study explores a regimen combining a novel nano-drug, chemotherapy, and precise targeted therapy, aiming to find a more effective and safer treatment option for patients with advanced bone and soft tissue sarcomas who have failed first-line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bone sarcoma | Experimental | Drug: Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib |
| soft tissue sarcoma | Experimental | Drug: Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Informed Consent: The subject has signed the informed consent form after receiving and understanding full explanation regarding the trial's purpose, procedures, anticipated efficacy, pharmacological actions, and risks.
- Target Population:
- Physical Examination and Laboratory Results:
- Hepatitis B: Subjects positive for HBsAg are eligible if, in the investigator's judgment, their chronic hepatitis B is stable and does not increase the subject's risk.
- Cardiac Function: No symptomatic cardiac insufficiency at baseline (NYHA class ≤ II) and no clinically significant ECG abnormalities.
Key exclusion criteria (17 listed)
- Known allergy or intolerance to any component or excipient of the investigational products.
- Primary brain tumor or central nervous system (CNS) metastases (including leptomeningeal metastases), except for a single, well-controlled, asymptomatic brain metastasis. CNS tumors still presenting with increased intracranial pressure or neuropsychiatric symptoms after treatment.
- Uncontrolled acute or chronic infections, or other severe concurrent medical conditions.
- History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Active hepatitis or hepatic tumor burden exceeding 50% of the total liver volume.
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 |
|---|---|---|
| Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib1. Paclitaxel Polymer Micelles + Gemcitabine: Paclitaxel Micelles: 230 mg/m² (C1), then 300 mg/m² if tolerated, IV (≥3h), D8, Q3W. Gemcitabine: 800 mg/m², IV (90min), D1\&D8, Q3W. Planned for 6 cycles, may extend >6 cycles (based on investigator assessment of continued clinical benefit and patient tolerance) with patient self-pay for Paclitaxel Micelles. 2. Lenvatinib (Bone Sarcoma): 12-16 mg daily (8-12 mg if <60 kg), continuous oral dosing until progression. General Rules: Dose adjustments based on CTCAE v5.0. For patients with systemic benefit (PR/SD per RECIST 1.1 for ≥2 cycles), localized interventions (e.g., surgery, radiation) are permitted following MDT evaluation and with protocol-defined study drug adjustments. | Drug | bone sarcoma |
| Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib1. Paclitaxel Polymer Micelles + Gemcitabine: Paclitaxel Micelles: 230 mg/m² (C1), then 300 mg/m² if tolerated, IV (≥3h), D8, Q3W. Gemcitabine: 800 mg/m², IV (90min), D1\&D8, Q3W. Planned for 6 cycles, may extend >6 cycles (based on investigator assessment of continued clinical benefit and patient tolerance) with patient self-pay for Paclitaxel Micelles. 2. Anlotinib (Soft Tissue Sarcoma): 12 mg daily (8 mg if <45 kg), oral (2 wks on/1 wk off) until progression. General Rules: Dose adjustments based on CTCAE v5.0. For patients with systemic benefit (PR/SD per RECIST 1.1 for ≥2 cycles), localized interventions (e.g., surgery, radiation) are permitted following MDT evaluation and with protocol-defined study drug adjustments. | Drug | soft tissue sarcoma |
Primary outcome
Overall Response Rate
Time frame: assessed up to 1 year
5 secondary outcomes
Progression-Free-Survival
Time frame: assessed up to 1 year
Disease Control Rate
Time frame: assessed up to 1 year
Duration of Response
Time frame: assessed up to 1 year
Time To Progression
Time frame: assessed up to 1 year
Incidence of adverse events
Time frame: assessed up to 1 year
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary publication of this trial (including de-identified demographic, clinical, efficacy, and safety data), the study protocol, statistical analysis plan, and informed consent form will be made available. Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal that has been approved by an independent review committee. Proposals should be directed to the corresponding author. Time Frame: Data will become available 12 months after the primary results publication and will remain accessible for 5 years. Mechanism: Data will be provided in a secure, de-identified format via a trusted data repository or upon direct request, subject to a data sharing agreement.
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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 Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib and Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib in people with Sarcoma, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenliang Zhou, MD (18930170437, billzcl@msn.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: assessed up to 1 year). 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 22 Jan 2026.