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

NCT06562673 | Completed Phase 1

• 1 other identifier: 2024-098-(1)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Osteosarcoma; Bone Cancer

Keywords

osteosarcoma; intra-arterial; anti-angiogenesis inhibitor; endostatin; cisplatin

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Safety analysis (adverse events) according to CTCAE 5.0

  From enrollment to the end of treatment at 1-month

• Incidence of tumor response

  according to tumor cell necrosis rate (TCNR) of tumor tissue sample after surgery.

  From enrollment to the end of treatment at 1 month

Secondary Outcomes (1)

• Microvessel density

  From enrollment to the end of treatment at 1 month

Study Arms (1)

IA cisplatin plus endostatin

EXPERIMENTAL

Intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy

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

Interventions

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

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.

Also known as: intra-arterial treatment

IA cisplatin plus endostatin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Combined history of acute injury, infection and surgery in the last 3 months;
• Those with severe liver and kidney function abnormalities;
• Those who are using anti-inflammatory drugs;
• Pre-existing hematologic diseases before treatment;
• Combined with other malignant tumors;
• Diagnosed with autoimmune disease or using steroid drugs for more than 1 month before treatment;
• Suffering from mental illness or cognitive dysfunction.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

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

Shanghai, 200233, China

Location

Related Publications (10)

• Xu H, Huang Z, Li Y, Zhang Q, Hao L, Niu X. Perioperative rh-endostatin with chemotherapy improves the survival of conventional osteosarcoma patients: a prospective non-randomized controlled study. Cancer Biol Med. 2019 Feb;16(1):166-172. doi: 10.20892/j.issn.2095-3941.2018.0315.

  PMID: 31119057 BACKGROUND

• Shaikh R, Munoz FG. Endovascular approaches in pediatric interventional oncology. CVIR Endovasc. 2021 Jan 2;4(1):2. doi: 10.1186/s42155-020-00190-7.

  PMID: 33387076 BACKGROUND

• Xie L, Xu J, Dong S, Gao J, Tang X, Yan T, Yang R, Guo W. Gain and loss from transcatheter intra-arterial limb infusion of cisplatin for extremity osteosarcoma: a retrospective study of 99 cases in the past six years. Cancer Manag Res. 2019 Jul 30;11:7183-7195. doi: 10.2147/CMAR.S214604. eCollection 2019.

  PMID: 31447583 BACKGROUND

• Avritscher R, Javadi S. Transcatheter intra-arterial limb infusion for extremity osteosarcoma: technical considerations and outcomes. Tech Vasc Interv Radiol. 2011 Sep;14(3):124-8. doi: 10.1053/j.tvir.2011.02.004.

  PMID: 21767779 BACKGROUND

• Zhang HJ, Yang JJ, Lu JP, Lai CJ, Sheng J, Li YX, Hao Q, Zhang SM, Gupta S. Use of intra-arterial chemotherapy and embolization before limb salvage surgery for osteosarcoma of the lower extremity. Cardiovasc Intervent Radiol. 2009 Jul;32(4):672-8. doi: 10.1007/s00270-009-9546-2. Epub 2009 Mar 19.

  PMID: 19296158 BACKGROUND

• Wilkins RM, Cullen JW, Camozzi AB, Jamroz BA, Odom L. Improved survival in primary nonmetastatic pediatric osteosarcoma of the extremity. Clin Orthop Relat Res. 2005 Sep;438:128-36. doi: 10.1097/01.blo.0000179736.10871.76.

  PMID: 16131881 BACKGROUND

• Wilkins RM, Cullen JW, Odom L, Jamroz BA, Cullen PM, Fink K, Peck SD, Stevens SL, Kelly CM, Camozzi AB. Superior survival in treatment of primary nonmetastatic pediatric osteosarcoma of the extremity. Ann Surg Oncol. 2003 Jun;10(5):498-507. doi: 10.1245/aso.2003.03.061.

  PMID: 12794015 BACKGROUND

• Rao BN, Rodriguez-Galindo C. Intra-arterial cisplatin in osteosarcoma: same question, different answer. Ann Surg Oncol. 2003 Jun;10(5):481-3. doi: 10.1245/aso.2003.04.903. No abstract available.

  PMID: 12794009 BACKGROUND

• Wanebo HJ, Temple WJ, Popp MB, Constable W, Aron B, Cunningham SL. Preoperative regional therapy for extremity sarcoma. A tricenter update. Cancer. 1995 May 1;75(9):2299-306. doi: 10.1002/1097-0142(19950501)75:93.0.co;2-y.

  PMID: 7712441 BACKGROUND

• Bielack SS, Bieling P, Erttmann R, Winkler K. Intraarterial chemotherapy for osteosarcoma: does the result really justify the effort? Cancer Treat Res. 1993;62:85-92. doi: 10.1007/978-1-4615-3518-8_12.

  PMID: 8096763 BACKGROUND

MeSH Terms

Conditions

Osteosarcoma; Bone Neoplasms

Interventions

endostar protein

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Hong-Tao Li, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 20, 2024
• Study Start: December 3, 2024
• Primary Completion: April 17, 2025
• Study Completion: July 20, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-08

Locations

CN (1)