The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age75+
SponsorSecond Affiliated Hospital of Soochow University

About this trial

This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.

Eligibility criteria

Qualifiers

Aged 75 years and above

Standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy

ECOG(Eastern Cooperative Oncology Group) performance is 0-3

Life expectancy greater than 3 months

Disqualifiers

Current pregnancy or lactation

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)

Uncontrolled epilepsy, central nervous system diseases or mental illness

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

Trial design

Treatments tested in this trial

  • ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin

Treatment groups

29 Participants
are divided into 1 treatment group