Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05809336
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2023-03-30
Brief Title:
Gut Microbial Metabolites Inosine Combined With PD-1PD-L1 Inhibitor for Patients With Malignant Advanced Solid Tumors
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Gut Microbial Metabolites Inosine Combined With PD-1PD-L1 Inhibitor for Patients With Malignant Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-03
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:
We conducted a single-center prospective randomized Parallel controls open labels Clinical StudiesThe study is about Gut Microbial Metabolites Inosine Combined With PD-1PD-L1 Inhibitor for Patients with malignant Advanced Solid Tumors One group was the inosine group the other group was the non-inosine groupThe treatment regimen of inosine group inosine PD-1PD-L1 inhibitor chemotherapytargeting and the treatment regimen of non-inosine group PD-1PD-L1 inhibitor chemotherapytargetingThe primary study endpoints were overall survival OS and progression-free survival PFS and the secondary study endpoints were objective remission rate ORR and disease control rate DCR comparing the two groups
Detailed Description:
We conducted a single-center prospective randomized Parallel controls open labels Clinical StudiesThe study is about Gut Microbial Metabolites Inosine Combined With PD-1PD-L1 Inhibitor for Patients with malignant Advanced Solid TumorsOne group was the inosine group the other group was the non-inosine group A total of 172 patients with advanced malignant solid tumors were collected from Capital Medical University Beijing Friendship Hospital and randomly assigned to two groups according to 11 86 patients in the inosine group and 86 patients in the non-inosine group The regimen of inosine treatment group was inosine PD-1PD-L1 inhibitor chemotherapytargeting and the treatment regimen of non-inosine treatment group was PD-1PD-L1 inhibitor chemotherapytargetingevery 2 or 3 weeks protocol until the subjects disease progresses death intolerable adverse events the investigator determines that there is no benefit from continued treatment or other termination criteria are met pregnancy individual patient reasons or co-morbidities the subject requests withdrawal from the study withdrawal of informed consent and loss of visitAnti-tumor efficacy is evaluated every 23 cycles every 6 weeks based on computed tomography CT or magnetic resonance imaging MRI results and their tumor markers according to RECIST v11 criteria
Inosine tablets were purchased from Tianjin Jinshi dosage 02g orally 3 timesday PD-1PD-L1 inhibitors chemotherapy and targeted combination therapy regimens were developed by the investigators according to the NCCN guidelines and CSCO guidelines and the patients condition and its staging
Inosine tablets were purchased from Tianjin Jinshi dosage 02g orally 3 timesday PD-1PD-L1 inhibitors chemotherapy and targeted combination therapy regimens were developed by the investigators according to the NCCN guidelines and CSCO guidelines and the patients condition and its staging
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?:
None
Is an FDA AA801 Violation?:
None