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Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation: a Clinical Study
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Shanghai Chest Hospital
Shanghai, China
Start Date
January 1, 2022
Primary Completion Date
September 30, 2024
Completion Date
December 31, 2024
Last Updated
July 15, 2022
42
ESTIMATED participants
sintilimab combined with anlotinib
DRUG
sintilimab monotherapy
DRUG
Lead Sponsor
Shanghai Chest Hospital
NCT06305754
NCT07190248
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07100080