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Efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) 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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088085
Enrollment
Unknown
Registered
2024-08-12
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteosarcoma

Interventions

Experimental group:Intravenous (2-4 cycles): Methotrexate 10g/m2
Doxorubicin 60-75mg/m2 Arteries (2-4 cycles): Recombinant endostatin 150mg infused for 6 hours
Cisplatin 120mg/m2 infusion for 6 hours

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion 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; (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

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.

Design outcomes

Primary

MeasureTime frame
Safety analysis ;Tumor cell necrosis rate (TCNR);

Secondary

MeasureTime frame
Analysis of Postoperative Specimen Characteristics of Osteosarcoma;

Countries

China

Contacts

Public ContactHong-Tao Li, Yong-Gang Wang

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Lhtmed@shsmu.edu.cn+86 21 2405 8430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026