Clinical trial · Interventional
Intra-arterial Cisplatin Plus Rh-endostatin 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cancer | Malignant Bone Neoplasm | ALIAS | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IA cisplatin plus endostatin
- description
- Intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy
- interventionNames
- Drug: intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- From enrollment to the end of treatment at 1-month
- description
- Safety analysis (adverse events) according to CTCAE 5.0
- measure
- Incidence of tumor response
- timeFrame
- From enrollment to the end of treatment at 1 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of osteosarcoma patients aged 12-40 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.
References
Publications (10)
- BACKGROUNDXu 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
- BACKGROUNDShaikh 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
- BACKGROUNDXie 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
- BACKGROUNDAvritscher 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
- BACKGROUNDZhang 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
- BACKGROUNDWilkins 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
- BACKGROUNDWilkins 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.