Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544460
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer Patients With PARP Inhibitors Resistance a Phase II Clinical Study
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:
None
Brief Summary:
At present the treatment of recurrent ovarian cancer after PARP inhibitor therapy is quite challenging and there is no research on the application of hyperthermic intraperitoneal chemotherapyHIPEC for the above-mentioned patients Therefore this study aims to explore the safety and efficacy of secondary cytoreduction combined with hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer after maintenance therapy with PARP inhibitors through a single-center prospective single-arm phase II clinical trial The goal is to explore the treatment options for ovarian cancer patients in the era of PARP inhibitors thereby improving the overall treatment level and prognosis of ovarian cancer
Detailed Description:
1 Overall design This is a single-center prospective single-arm phase II clinical trial to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for recurrent ovarian cancer after maintenance therapy with PARP inhibitors
2 Sample size calculation This clinical trial aims to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for the maintenance treatment of recurrent ovarian cancer with PARP inhibitors The median progression-free survival of patients who received maintenance therapy with PARP inhibitors in our center is 11 months It is expected that HIPEC can reduce the risk of recurrence by 30 After 1 year of enrollment and 2 years of follow-up the alpha value is 005 Considering the participants who withdrew from the study midway or dropped out due to loss to follow-up this study intends to include 94 participants
3 Methods Using the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument after the surgical operation is completed four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively Connect all pipelines and preheat the instrument before starting treatment The treatment temperature is controlled at 43 01 the treatment time is 90 minutes and the circulation pump flow rate is 400-600mlmin Within 48 hours after the surgery cisplatin 75mg was added to 3000ml of physiological saline for intraperitoneal hot infusion
4 Data statistics Enter data and use SPSS statistical software for statistical analysis Statistical analyst Clinical Statistics Department of Fudan University Cancer Hospital Mailing address 270 Dongan Road Shanghai
2 Sample size calculation This clinical trial aims to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for the maintenance treatment of recurrent ovarian cancer with PARP inhibitors The median progression-free survival of patients who received maintenance therapy with PARP inhibitors in our center is 11 months It is expected that HIPEC can reduce the risk of recurrence by 30 After 1 year of enrollment and 2 years of follow-up the alpha value is 005 Considering the participants who withdrew from the study midway or dropped out due to loss to follow-up this study intends to include 94 participants
3 Methods Using the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument after the surgical operation is completed four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively Connect all pipelines and preheat the instrument before starting treatment The treatment temperature is controlled at 43 01 the treatment time is 90 minutes and the circulation pump flow rate is 400-600mlmin Within 48 hours after the surgery cisplatin 75mg was added to 3000ml of physiological saline for intraperitoneal hot infusion
4 Data statistics Enter data and use SPSS statistical software for statistical analysis Statistical analyst Clinical Statistics Department of Fudan University Cancer Hospital Mailing address 270 Dongan Road Shanghai
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