Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513301
Status:
UNKNOWN
Last Update Posted:
2020-08-14
First Post:
2020-08-12
Brief Title:
Efficacy and Safety of Sintilimab With or Without Radiotherapy in Patients With Recurrent or IV NSCLC EGFR - ALK - After Failure of Platinum-based Chemotherapy A RandomizedOpen Labled Phase II Clinical Study
Sponsor:
Shanghai Cancer Hospital China
Organization:
Shanghai Cancer Hospital China
Study Overview
Official Title:
Efficacy and Safety of Sintilimab With or Without Radiotherapy in Chinse Patients With Recurrent or IV NSCLC EGFR - ALK - After Failure of Platinum-based Chemotherapy A Randomized Controlled Phase II Clinical Study
Status:
UNKNOWN
Status Verified Date:
2020-08
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:
Lung cancer incidence and mortality have been increasing steeply in the past thirty years in the mainland of China More than 80 of lung cancer is non-small cell lung cancer NSCLC More than 40 of NSCLC patients are found to be in stage IIIb or IV which is not resectable The 5-year survival rate for this group of patients is less than 5 in the SEER database Currently the NCCN guidelines recommend platinum-containing double-drug chemotherapy as the first- line standard of care for advanced NSCLC without driver gene mutations and treatment options after failure of first-line chemotherapy are limited Immune Checkpoint Inhibitors ICIs provide new treatment options and in addition radiotherapy can also be used in selected patients with advanced NSCLC especially in patients with oligo progression where irradiation of the thoracic primary lesions can improve the patients respiratory-related symptoms reduce the tumor burden improve the patients quality of life and prolong survival in some patients Therefore we propose that combination of immunotherapy and radiotherapy to the primary lesion for these patients who are generally in good KPS status may result in improved quality of life and prolonged survival To date there have been no clinical studies of immunotherapy combined with primary lesions radiation therapy in patients with advanced non-small cell lung cancer driver gene-negative after chemotherapy failure or recurrence so we designed this prospective randomized controlled investigator-initiated phase II clinical study with the primary objective of evaluating the efficacy of combined immunotherapy and primary lesions radiation therapy in this patient population This trial aims at investigating the feasibility and efficacy of this treatment strategy
Detailed Description:
None
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