Combining intra-arterial cisplatin and rh-endostatin with chemotherapy for osteosarcoma
Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma
This study is testing a new way to treat osteosarcoma by combining a targeted delivery of two drugs with standard chemotherapy to see if it helps patients feel better and fight the cancer more effectively.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, immunotherapy, doxorubicin |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06562673 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of administering intra-arterial cisplatin alongside the anti-angiogenesis inhibitor rh-endostatin, combined with standard chemotherapy for patients diagnosed with osteosarcoma. The study will involve newly diagnosed patients aged 18-40, who will receive high-dose methotrexate and adriamycin intravenously, while rh-endostatin and cisplatin will be delivered directly to the tumor via a catheter. The goal is to determine if this approach increases tumor necrosis rates compared to traditional treatments, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-40 with a confirmed diagnosis of osteosarcoma who are willing to undergo neoadjuvant chemotherapy.
Not a fit: Patients with severe liver or kidney dysfunction, recent acute injuries, or other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance tumor response rates and improve survival outcomes for osteosarcoma patients.
How similar studies have performed: Previous studies have shown promising results with similar intra-arterial chemotherapy approaches, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of osteosarcoma patients aged 18-40 years old; 2. Accept to receive treatment with neoadjuvant chemotherapy regimen and completing the standard treatment course; Voluntary informed consent, joining the study with good compliance. 3. 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. Exclusion Criteria: 1. Combined history of acute injury, infection and surgery in the last 3 months; 2. Those with severe liver and kidney function abnormalities; 3. Those who are using anti-inflammatory drugs; 4. Pre-existing hematologic diseases before treatment; 5. Combined with other malignant tumors; 6. Diagnosed with autoimmune disease or using steroid drugs for more than 1 month before treatment; 7. Suffering from mental illness or cognitive dysfunction.
Where this trial is running
Shanghai
- Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital, — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Hong-Tao Li, Dr. — Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital
- Study coordinator: Hong-Tao Li, Dr.
- Email: Lhtmed@shsmu.edu.cn
- Phone: 86-21-24058430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.