Clinical trial NCT06112041: The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
Official title: The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors(PRaG9.0)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Carcinoma
Solid Tumor
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 29
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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
* 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
* Signed informed consent form

Exclusion Criteria:

* 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
* Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation
* Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes
* Allergic to any of the ingredients used in the study
* 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
* Acute and chronic tuberculosis infection
* Other disorders with clinical significance according to the researcher's judgment

Primary outcomes:
measure: Objective Response Rate #ORR#
timeFrame: 36 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 36 months
measure: Disease control rate (DCR)
timeFrame: 36 months
measure: Overall survival (OS)
timeFrame: 36 months
measure: Adverse event
timeFrame: 36 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
Study officials:
References: