Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403111
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-27
Brief Title:
FMTImmunotherapyChemotherapy as First-line Treatment for Driver-gene Negative Advanced NSCLC
Sponsor:
Changzhou No2 Peoples Hospital
Organization:
Changzhou No2 Peoples Hospital
Study Overview
Official Title:
Fecal Microbiota Transplantation Combined With Immunotherapy and Chemotherapy as First-line Treatment for Driver-gene Negative Advanced Non-small Cell Lung Cancer a Prospective Multicenter Single-arm Exploratory Study FMT-JSNO-02
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:
None
Brief Summary:
This study plans to reconstruct intestinal microecology through fecal microbiota transplantation FMT and combine first-line standard therapy to enhance the anti-tumor immune effect at the same time thereby extending the progression-free survival of patients and improving the prognosis of patients
Detailed Description:
This is a prospective single-arm multicenter exploratory clinical study That is eligible patients with driver-gene negative ECOG PS 0-1 PD-L150 advanced non-small cell lung cancer who have not received prior treatment will be screened after signing informed consent and receive FMT combined with tislelizumab pemetrexed and platinum-based therapy for adenocarcinoma patients albumin-bound paclitaxel and platinum-based therapy for squamous cell carcinoma patients RECIST v11 was used for tumor evaluation every 6 weeks during treatment NCI-CTCAE 50 was used for safety assessment every 3 weeks Adverse events were recorded throughout the study to 30 days after the end of treatment Treatment continues until disease progression subject withdraws informed consent loss of follow-up or death Patients should provide 10ml whole blood samples and fecal samples at baseline after two cycles of treatment before maintenance treatment and after two cycles of maintenance treatment for the detection of efficacy prediction markers each cycle is 21 days
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