Apatinib Combined With SHR-1210 Injection in the Treatment of Patients With Removable IB-IIIA NSCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04133337|
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases Neoplasms Respiratory Tract Diseases Thoracic Neoplasms Non-small-cell Lung Cancer||Drug: Apatinib Drug: SHR-1210||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||One-arm Exploratory Study on the Efficacy and Safety of Apatinib Combined With SHR-1210 Injection (PD-1 Antibody) in the Treatment of Removable IB-IIIA Non-small Cell Lung Cancer|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Apatinib Combined With SHR-1210 Injection
The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 7-8 weeks after the first dose.
Apatinib Mesylate Tablets
Camrelizumab for Injection
- Major pathologic response rate(MPR)(<10% viable tumor cells) [ Time Frame: At time of surgery ]To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Apatinib Combined With SHR-1210 Injection.
- Disease Control Rate (DCR) [ Time Frame: up to 2 years ]the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.
- Overall response rate (ORR) [ Time Frame: up to 2 years ]the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator
- Disease-free survival (DFS) [ Time Frame: up to 2 years ]Defined as the time from date of surgery until recurrence of tumor or death from any cause
- Incidence of irAEs [ Time Frame: up to 2 years ]Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
- Incidence of SAEs [ Time Frame: up to 2 years ]Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133337
|Contact: Juan Li, MDfirstname.lastname@example.org|
|Sichuan Cancer Hospital||Not yet recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Juan Li, MD +8613880276636 email@example.com|
|Principal Investigator:||Juan Li, MD||Sichuan Cancer Hospital and Research Institute|