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New treatment option for Sarcoma
Official title MAGNATE-S: Paclitaxel Polymer Micelles Combo in Advanced Sarcoma
ClinicalTrials.gov ID: NCT07359053
What this study is testing
What is Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib?
Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 70
You may be able to join if
- Informed Consent: The subject has signed the informed consent form after receiving and understanding full explanation regarding the trial's purpose...
- Target Population:
- Histologically confirmed advanced/metastatic bone or soft tissue sarcoma. (If recurrence or metastasis is not definitive, a biopsy with frozen...
- At least one measurable lesion per RECIST 1.1 criteria.
- Disease progression after prior first-line standard chemotherapy; ECOG performance status 0-2.
You likely can't join if
- 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...
- 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)...
See the full eligibility criteria
- Informed Consent: The subject has signed the informed consent form after receiving and understanding full explanation regarding the trial's purpose, procedures, anticipated how well it works, pharmacological actions...
- 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...
- 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.
- 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...
- 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...
- 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: people 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).
- people 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 people must not be breastfeeding.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, CH, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, CH, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.