Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)
NCT05603013 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2022-11-02
Summary
This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer.
Conditions
- Carcinoma, Non-Small-Cell Lung
- Carcinoma Breast
Interventions
- DRUG
-
Vinorelbine Tartrate Oral
- RADIATION
-
Radiotherapy
hypofractionated radiotherapy
- DRUG
-
PD-1/PD-L1 inhibitor
PD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection
- DRUG
-
GM-CSF subcutaneous injection
- DRUG
-
IL-2
IL-2 subcutaneous injection
Sponsors & Collaborators
-
Second Affiliated Hospital of Soochow University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-30
- Primary Completion
- 2024-01-01
- Completion
- 2024-10-17
Countries
- China
Study Locations
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