MAGNATE-S: Paclitaxel Polymer Micelles Combo in Advanced Sarcoma

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. 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.

Conditions

• Sarcoma

Interventions

DRUG

Paclitaxel Polymer Micelles + Gemcitabine + Lenvatinib

1. 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

Paclitaxel Polymer Micelles + Gemcitabine + Anlotinib

1. 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.

Sponsors & Collaborators

• Shanghai 6th People's Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-25

Primary Completion

2027-09-30

Completion

2028-09-30

Countries

• China

Study Locations