Status:
RECRUITING
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Lead Sponsor:
Second Hospital of Shanxi Medical University
Conditions:
NSCLC
Nintedanib
Eligibility:
All Genders
18+ years
Brief Summary
This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined wi...
Eligibility Criteria
Inclusion
- 1\) Men or women who are over 18 years old (including 18 years old) when signing the informed consent form;
- 2\) Non-small cell lung cancer was confirmed by histology and could not be resected, and EGFR/ALK driver gene was confirmed negative by gene mutation examination;
- 3\) At least one measurable lesion with imaging examination (according to RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the lesion are ≥ 10 mm;
- 4\) within 3 days before treatment, the score according to ECOG is 0 \~ 1;
- 5\) Life expectancy ≥3 months;
- 6)The vital organs function well,
- 7)The subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up.
Exclusion
- 1\) Complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc.
- 2)Persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney;
- 3\) Hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occur within 3 months before the first administration, or there are bleeding symptoms and need intervention treatment (such as hemoptysis, hematuria and bloody stool), or high-risk factors with bleeding risk (such as tumor surrounding or invading important blood vessels, obvious necrosis or cavity around tumor, esophageal varices, etc.);
- 4\) Thrombosis or embolic diseases, abnormal blood coagulation function and bleeding tendency;
- 5\) Known or suspected to be allergic to the study drug and its auxiliary materials;
- 6\) The baseline pregnancy test of pregnant and lactating women or fertile women is positive.
- 7\) According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study.
Key Trial Info
Start Date :
August 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06570317
Start Date
August 24 2024
End Date
June 30 2026
Last Update
August 26 2024
Active Locations (7)
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1
Jincheng General Hospital
Jincheng, Shanxi, China
2
Jinzhong third people's hospital
Jinzhong, Shanxi, China
3
Frist Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
4
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China