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)

Last updated: October 29, 2022
Sponsor: Second Affiliated Hospital of Soochow University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05603013
JD-LK-2022-136-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 years and above;
  2. Diagnosed with histologically or cytologically-confirmed, standard treatment isineffective (disease progresses after treatment) or locally advanced or metastaticmalignant non-small cell lung cancer and breast cancer patients who cannot toleratestandard 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 neutrophilcount(ANC)≥1.0 x 10(9)/L#serum aspartate transaminase (AST) and serum alaninetransaminase (ALT) ≤3.0ULN, or AST and ALT≤5ULN with hepatic metastasis; Total serumcreatinine ≤1.5*ULN#
  6. Signed informed consent form# -

Exclusion

Exclusion Criteria:

  1. Current pregnancy or lactation# 2. History of other malignant tumors within 5 yearsprior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma insitu, basal or squamous cell skin cancer); 3. Uncontrolled epilepsy, central nervous systemdiseases or mental illness; 4. Currently active clinically significant cardiovasculardisease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equalto Class 2 congestive heart failure as defined by the New York Heart Association FunctionalClassification, or history of myocardial infarction unstable angina, or acute coronarysyndrome within 6 months prior to enrollment in the study; 5. Received allogeneichematopoietic stem cell transplantation or solid organ transplantation; 6. Other serious,uncontrolled concomitant diseases that may affect protocol compliance or interpretation ofoutcomes, including active opportunistic infections or advanced (severe) infections,uncontrolled diabetes; 7. Allergic to any of the ingredients used in the study; 8. Ahistory of immunodeficiency, including HIV positive or other acquired or congenitalimmunodeficiency disease, or a history of organ transplantation, or other immune-relateddisease requiring long-term oral hormone therapy; 9. Acute and chronic tuberculosisinfection; 10. Other disorders with clinical significance according to the researcher'sjudgment.

Study Design

Total Participants: 45
Study Start date:
October 30, 2022
Estimated Completion Date:
October 17, 2024

Connect with a study center

  • Second Affiliated Hospital of Soochow University

    Suzhou,
    China

    Site Not Available

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