NCT06562673CompletedPhase 1/2
Intra-arterial Cisplatin Plus Rh-endostatin Combined With Systematic Chemotherapy in Osteosarcoma
Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
The goal of this clinical trial is to learn the efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma. The main questions it aims to answer are: * Is it safe when rh-endostatin and cisplatin are administered intra-arterially? * Does intra-arterial cisplatin plus rh-endostatin increase the rate of tumor necrosis compared with traditional treatment? Researchers will treat newly diagnosed osteosarcoma patients with systematic treatment and local treatment. For systematic treatment, regular high-dose methotrexate and adriamycin will be administered intravenously. For local treatment, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion. Local treatment is conducted by insertion of a catheter percutaneously using the Seldinger technique through the brachial or femoral artery under local anesthesia. Participants will: • Receive local combined with systematic treatment once every 2-3 weeks for 2-4 cycles before surgery.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 10 Aug 2024
- Start date
- 3 Dec 2024
- Primary completion date
- 17 Apr 2025
- Lead sponsor
- Shanghai 6th People's Hospital
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT06562673
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 10
- From 3 Dec 2024 to the primary completion date, 17 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who are using anti-inflammatory drugs;
- Diagnosed with autoimmune disease or using steroid drugs for more than 1 month before treatment;
Other illness
- Combined history of acute injury, infection and surgery in the last 3 months;
- Pre-existing hematologic diseases before treatment;
- Combined with other malignant tumors;
- Suffering from mental illness or cognitive dysfunction.
Other
- Those with severe liver and kidney function abnormalities;
Who the study is looking for
- Histologically or cytologically confirmed diagnosis of osteosarcoma patients aged 12-40 years old;
- Accept to receive treatment with neoadjuvant chemotherapy regimen and completing the standard treatment course; Voluntary informed consent, joining the study with good compliance.
- Have detailed medical data (such as medical history data, laboratory reports of blood routine and liver and kidney functions, pathology reports, etc.), and complete records of postoperative follow-up.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital, Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.