MedTrace Logo

Intra-arterial Cisplatin Plus Rh-endostatin Combined With Systematic Chemotherapy in Osteosarcoma

NCT06562673 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)

After insertion of a catheter percutaneously by using the Seldinger technique through the brachial or femoral artery under local anesthesia, 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.

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    lead OTHER

Principal Investigators

  • Hong-Tao Li, Dr. · Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2025-04-17
Completion
2025-07-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06562673 on ClinicalTrials.gov