Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441344
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-19
Brief Title:
Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell
Sponsor:
Taizhou Hospital
Organization:
Taizhou Hospital
Study Overview
Official Title:
First-line Etoposide Combined With Platinum-based Chemotherapy Followed by Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell Carcinoma - A Randomized Controlled Multicenter Phase III Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
SCLC
Brief Summary:
This is a randomized open multicenter Phase III clinical study A total of 136 participants are planned to be enrolled and randomly assigned to either the experimental group platinumetoposide toripalimab plus anlotinib or the control group platinumetoposide toripalimab toripalimab in a 11 ratio The primary efficacy measures include PFS while secondary endpoints include OS DOR ORR DCR progression free survival at 6 and 12 months overall survival at 12 and 18 months health-related quality of life FACT-L safety etc And in the III clinical study tissue samples were collected before treatment and tumor tissue and blood samples were taken from some patients after 3 cycles of maintenance treatment and treatment progression for single-cell sequencing and transcriptome sequencing to verify the underlying mechanism research
Detailed Description:
This study plans to enroll 136 subjects and randomly allocate them in a 11 ratio to the experimental group platinumetoposide toripalimab plus anlotinib and the control group platinumetoposide toripalimab toripalimab The experimental group was given etoposide 100 mgm2 d1-3carboplatin AUC 5 d1cisplatin 25 mgm2 D1-3 chemotherapy regimen for patients who have received 4-6 cycles chemotherapy sessions including PR CR SD they will enter the maintenance treatment phase and receive an oral dose of 12 mg of anlotinib on days 1-14 combined with 240 mg toripalimab for maintenance treatment The control group was given etoposide 100 mgm2 d1-3carboplatin AUC 5 d1cisplatin 25mgm2 d1toripalimab 240 mg d1 including PR CR SD who have been treated 4-6 cycles will enter the maintenance treatment period and receive maintenance treatment with toripalimab 240 mg d1 The above treatment regimen lasts for 21 days per cycle until disease progression or Intolerable adverse reactions occur or researchers believe that patients are not suitable for continued medication After the subject terminates or withdraws from this study the researcher may adopt reasonable follow-up treatment based on the subjects condition All patients will be followed up until death or the deadline for data collection Collect pathological tissue samples before treatment for genetic testing Before using maintenance therapy medication after 1 cycle of maintenance therapy and during progression after 3 cycles of treatment some patients are selected for puncture biopsy sampling after treatment progression Perform sequencing and biomarker inspection Follow up on PFS OS ORR DCR adverse reactions etc in two groups of patients Before maintenance therapy researchers are allowed to perform local radiotherapy based on the patients actual situation such as cranial radiotherapy bone metastasis radiotherapy etc but radiotherapy for the target lesion is not allowed However additional treatments related to tumors including traditional Chinese medicine and radiation therapy are not allowed during the maintenance treatment process The primary endpoints of this study were objective progression free survival PFS and overall survival OS evaluated according to the RECIST v11 criteria while secondary endpoints were duration of response DOR overall objective response rate ORR disease control rate DCRand safety
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