Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562673
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Intra-arterial Cisplatin Plus Rh-endostatin Combined With Systematic Chemotherapy in Osteosarcoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin Endostar Combined With Systematic Chemotherapy in Osteosarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IACE-OS
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 mgm2 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
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 mgm2 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
Detailed Description:
Osteosarcoma OS is the most common bone cancer in children and young adolescents Despite the emergence of new therapeutic modalities such as targeted therapy and immunotherapy chemotherapy remains the standard treatment The current standard treatment for osteosarcoma is the preoperative chemotherapy surgery and postoperative chemotherapy Preoperative chemotherapy or neoadjuvant chemotherapy and neoadjuvant chemotherapeutic agents include cisplatin adriamycin methotrexate The use of preoperative chemotherapy has increased the 5-year survival rate from 20 to 60-70 Over the past 40 years limited progress has been made in improving survival outcomes in patients with OS
Transcatheter arterial infusion TAI is the direct infusion of drugs in the tumor blood supply artery which can overcome the physiological barrier that some intravenous drug can not pass thus significantly increasing the local drug concentration in the tumor and improving the therapeutic efficacy Studies have shown that the combination of intravenous doxorubicin and intra-arterial cisplatin infusion before surgery resulted in a favorable histological response in 87 of enrolled patients with a 10-year survival rate of 93 and an event-free survival rate of 86
Recombinant endostatin an anti-angiogenic drug approved by the National Medical Products Administration of China in 2005 for the treatment of non-small cell lung cancer In preclinical studies synergistic antitumor efficacy was observed in an osteosarcoma mouse model with the addition of rh-endostatin to doxorubicin In the clinical study of osteosarcoma after comparing 58 patients with stage IIB osteosarcoma treated with chemotherapy combined with endostatin and 272 patients treated with chemotherapy alone results show that the 5-year DMFS distant metastasis-free survival of the control group 61 was significantly lower than that of the rh-endostatin group 79 P 0013 The 5-year OS of the control group 74 was significantly lower than that of the rh-endostatin treatment group 87 P 0029 These results suggest that endostatin combined with chemotherapy for osteosarcoma significantly improves distant metastasis-free survival with tolerable adverse effects and is worthy of further clinical investigation
Therefore the investigators propose that arterial infusion of endostatin and cisplatin combined with systematic therapy might improve the treatment efficacy in preoperative course
Transcatheter arterial infusion TAI is the direct infusion of drugs in the tumor blood supply artery which can overcome the physiological barrier that some intravenous drug can not pass thus significantly increasing the local drug concentration in the tumor and improving the therapeutic efficacy Studies have shown that the combination of intravenous doxorubicin and intra-arterial cisplatin infusion before surgery resulted in a favorable histological response in 87 of enrolled patients with a 10-year survival rate of 93 and an event-free survival rate of 86
Recombinant endostatin an anti-angiogenic drug approved by the National Medical Products Administration of China in 2005 for the treatment of non-small cell lung cancer In preclinical studies synergistic antitumor efficacy was observed in an osteosarcoma mouse model with the addition of rh-endostatin to doxorubicin In the clinical study of osteosarcoma after comparing 58 patients with stage IIB osteosarcoma treated with chemotherapy combined with endostatin and 272 patients treated with chemotherapy alone results show that the 5-year DMFS distant metastasis-free survival of the control group 61 was significantly lower than that of the rh-endostatin group 79 P 0013 The 5-year OS of the control group 74 was significantly lower than that of the rh-endostatin treatment group 87 P 0029 These results suggest that endostatin combined with chemotherapy for osteosarcoma significantly improves distant metastasis-free survival with tolerable adverse effects and is worthy of further clinical investigation
Therefore the investigators propose that arterial infusion of endostatin and cisplatin combined with systematic therapy might improve the treatment efficacy in preoperative course
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None