Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470464
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Thalidomide Combined With Chemotherapy in the Treatment of Relapsed or Refractory Yolk Sac Tumor
Sponsor:
Shandong First Medical University
Organization:
Shandong First Medical University
Study Overview
Official Title:
Clinical Study of Thalidomide Combined With Chemotherapy in the Treatment of Relapsed or Refractory Yolk Sac Tumor in Children
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Remarkable progress has been made in treating germ-cell tumor GCT through the use of platinum-based regimens However part of yolk sac tumor YST with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment This leaves a gap in effective treatment which needs to be filled by novel therapeutic approaches This paper is the first one to report the treatment combining thalidomide with nab-paclitaxel gemcitabine and epirubicin T-TGA for children with repeated relapsed or refractory yolk sac tumor rrrYST
Detailed Description:
Thalidomide THD is currently widely used in the treatment of immune rheumatic diseases blood tumors and solid tumors Solid tumors are mostly used in the treatment of lung cancer liver cancer stomach cancer colorectal cancer pancreatic cancer etc and are limited to patients with advanced or advanced tumors The main mechanisms of its action are inhibition of angiogenesis immune regulation induction of apoptosis target teratogenesis and so on However whether from animal experiments or clinical studies thalidomide alone or in combination with chemotherapy has not been seen to have a very effective therapeutic effect or exact clinical application in the treatment of these solid tumors
According to the latest relevant case analysis reports and clinical trial results abroad TIP regimen is still the priority recommended treatment regimen in the previous data for children with recurrent and refractory malignant germ cell tumors However the combination of Sirolimus and TIC regimen nab-paclitaxel isocyclophosphamide carboplatin previously explored by our research group can greatly improve the remission rate of recurrent and refractory germinal cell tumors especially for recurrent and refractory yolk sac tumors a certain proportion can be cured or the opportunity for surgery and radiotherapy can be obtained to achieve cure However there are still some children who are insensitive or progress again after 2 cycles of remission For these children with multiple relapsed or particularly difficult yolk sac tumors there is no effective treatment plan in the world at present and there is no relevant clinical trial However through our clinical experience and understanding in the treatment process of these children The results of thalidomide combined with TGA chemotherapy regimen nab-paclitaxel gemcitabine epirubicin were satisfactory Therefore we hope to evaluate the therapeutic effectiveness and adverse reactions of this regimen through clinical trials so as to provide an effective treatment option for children with recurrent and refractory yolk sac tumor
This paper is the first one to report the treatment combining thalidomide with nab-paclitaxel gemcitabine and epirubicin T-TGA for children with repeated relapsed or refractory yolk sac tumor rrrYST
According to the latest relevant case analysis reports and clinical trial results abroad TIP regimen is still the priority recommended treatment regimen in the previous data for children with recurrent and refractory malignant germ cell tumors However the combination of Sirolimus and TIC regimen nab-paclitaxel isocyclophosphamide carboplatin previously explored by our research group can greatly improve the remission rate of recurrent and refractory germinal cell tumors especially for recurrent and refractory yolk sac tumors a certain proportion can be cured or the opportunity for surgery and radiotherapy can be obtained to achieve cure However there are still some children who are insensitive or progress again after 2 cycles of remission For these children with multiple relapsed or particularly difficult yolk sac tumors there is no effective treatment plan in the world at present and there is no relevant clinical trial However through our clinical experience and understanding in the treatment process of these children The results of thalidomide combined with TGA chemotherapy regimen nab-paclitaxel gemcitabine epirubicin were satisfactory Therefore we hope to evaluate the therapeutic effectiveness and adverse reactions of this regimen through clinical trials so as to provide an effective treatment option for children with recurrent and refractory yolk sac tumor
This paper is the first one to report the treatment combining thalidomide with nab-paclitaxel gemcitabine and epirubicin T-TGA for children with repeated relapsed or refractory yolk sac tumor rrrYST
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None