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)

Trial Title: 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)

NCT ID: NCT05603013

Condition: Carcinoma, Non-Small-Cell Lung
Carcinoma Breast

Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Breast Neoplasms
Vinorelbine
Immune Checkpoint Inhibitors

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Vinorelbine
Description: Vinorelbine Tartrate Oral
Arm group label: Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Intervention type: Radiation
Intervention name: Radiotherapy
Description: hypofractionated radiotherapy
Arm group label: Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Intervention type: Drug
Intervention name: PD-1/PD-L1 inhibitor
Description: PD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection
Arm group label: Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Intervention type: Drug
Intervention name: GM-CSF
Description: GM-CSF subcutaneous injection
Arm group label: Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Intervention type: Drug
Intervention name: IL-2
Description: IL-2 subcutaneous injection
Arm group label: Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Aged 18 years and above; 2. Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant non-small cell lung cancer and breast cancer patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy; 3. ECOG(Eastern Cooperative Oncology Group) performance is 0-3; 4. Life expectancy greater than 3 months; 5. T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L#serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0*ULN, or AST and ALT≤5*ULN with hepatic metastasis; Total serum creatinine ≤1.5*ULN# 6. Signed informed consent form# - Exclusion Criteria: 1. Current pregnancy or lactation# 2. History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer); 3. Uncontrolled epilepsy, central nervous system diseases or mental illness; 4. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study; 5. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 6. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes; 7. Allergic to any of the ingredients used in the study; 8. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy; 9. Acute and chronic tuberculosis infection; 10. Other disorders with clinical significance according to the researcher's judgment. -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Second Affiliated Hospital of Soochow University

Address:
City: Suzhou
Country: China

Start date: October 30, 2022

Completion date: October 17, 2024

Lead sponsor:
Agency: Second Affiliated Hospital of Soochow University
Agency class: Other

Source: Second Affiliated Hospital of Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05603013