Condition: Sarcoma · Sponsor: Shanghai 6th People's Hospital
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 …
This description comes directly from the study's public registry record.
Chenliang Zhou, MD · 18930170437 · billzcl@msn.cn
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| Shanghai Sixth Peolple'S Hospital | Shanghai, CH, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07359053