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)

Sponsor
Second Affiliated Hospital of Soochow University
Study ID
NCT05603013
Phase
PHASE2
Status
Unknown

Conditions

  • Carcinoma Breast
  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine Tartrate Oral
  • Radiotherapy — RADIATION
    hypofractionated radiotherapy
  • PD-1/PD-L1 inhibitor — DRUG
    PD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection
  • GM-CSF — DRUG
    GM-CSF subcutaneous injection
  • IL-2 — DRUG
    IL-2 subcutaneous injection

Study Details

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.

Key Dates

Start date
Oct 30, 2022
Status verified
Oct 2022
Primary completion
Jan 1, 2024
Completion
Oct 17, 2024

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
    Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Primary Outcome Measure

Objective Response Rate #ORR# [ Time Frame: 24 months ]

Central Contacts

Related Studies