Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed diagnosis of osteosarcoma patients aged 18-40 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.

Locations
Other Locations
China
Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital,
RECRUITING
Shanghai
Contact Information
Primary
Hong-Tao Li, Dr.
Lhtmed@shsmu.edu.cn
86-21-24058430
Backup
Yong-Gang Wang, Dr.
sirui666@163.com
86-21-24058430
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-10-20
Participants
Target number of participants: 10
Treatments
Experimental: IA cisplatin plus endostatin
Intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy
Sponsors
Leads: Shanghai 6th People's Hospital

This content was sourced from clinicaltrials.gov