Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-31 @ 3:06 AM
Study NCT ID:
NCT05460195
Status:
UNKNOWN
Last Update Posted:
2022-07-15
First Post:
2022-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation
Sponsor:
Shanghai Chest Hospital
Organization:
Study Overview
Official Title:
Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation: a Clinical Study
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
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:
To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.
Detailed Description:
Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.
In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.
This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.
In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.
This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.
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?: