Status:
UNKNOWN
A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer
Lead Sponsor:
Northern Jiangsu People's Hospital
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell...
Detailed Description
In this study, 16 patients with NSCLC were enrolled to explore the clinical effect of chemotherapy combined with local injection of Envafolimab. To determine whether the treatment of metastatic/recurr...
Eligibility Criteria
Inclusion
- 1\. The subjects volunteered to participate in the study, signed the informed consent form, and had good compliance;
- 2\. ECOG≤2 ;
- Life expectancy of ≥12 weeks；
- Age ≥18 years;
- 5\. Diagnosed by histological examination and/or cytology examination, and imaging evaluation (refer to RECIST 1.1) for advanced central NSCLC;
- 6\. He had not received systemic chemotherapy previously.
- Had at least one measurable tumor lesion according to RECIST v1.1；That is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and the short diameter of a single lymph node on CT scan is ≥15mm；
- Have adequate organ function。
Exclusion
- This study was conducted five years prior to the initiation of treatment or concurrently with other malignant tumors.
- 2\. Have family history of cancer.
- had previously undergone any form treatment, such as surgery, chemotherapy, radiation therapy, etc.
- Only individuals experiencing grade 1 or higher unmitigated toxic effects (excluding alopecia and fatigue) resulting from previous therapies were eligible for enrollment; neurologic toxicity needed to return to grade 1 or lower or baseline before participation.
- Subjects with severe and/or uncontrollable disease progression；
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by the investigator.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06108726
Start Date
October 18 2023
End Date
October 18 2025
Last Update
October 31 2023
Active Locations (1)
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1
Northern Jiangsu People's Hospital
Suzhou, Jiangsu, China, 215163