Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341530
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-12
Brief Title:
Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
Prospective Clinical Study of Anlotinib Hydrochloride Capsule Combined With Penpulimab Injection in the Front-line Treatment of Advanced Non-small Cell Lung Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-03
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:
In recent years with the emergence and clinical application of anti-angiogenesis therapy the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase Anti-angiogenic therapy can improve the hypoxia state of tumor tissue normalize blood vessels relieve immune suppression in tumor microenvironment increase the degree of infiltration of immune cells and fully activate immune cells to achieve the effect of tumor immunity Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment and the combination of the two can have synergistic effects
This study intends to treat patients with advanced non-small cell lung cancer NSCLC confirmed by pathology with the combination of anlotinib and penpulimab injection and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients and has important clinical value for the treatment of advanced lung cancer
This study intends to treat patients with advanced non-small cell lung cancer NSCLC confirmed by pathology with the combination of anlotinib and penpulimab injection and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients and has important clinical value for the treatment of advanced lung cancer
Detailed Description:
This study intends to treat patients with advanced non-small cell lung cancer NSCLC confirmed by pathology with the combination of anlotinib and penpulimab injection and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC To describe the therapeutic mode of anlotinib hydrochloride combined with penpulimab injection in the treatment of patients with non-small cell lung cancer including treatment regimen dosage number of treatment cycles dose adjustmentdiscontinuation and reasons and treatment outcomesPrimary endpoints Progression-free survival PFS disease control rate DCR objective response rate ORR Secondary endpoints Overall survival OS quality of life score QoL Safety evaluation indicators vital signs laboratory indicators adverse events AE serious adverse events SAE
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