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

Soochow University

Status and phase: Not yet enrolling; Phase 2

Conditions: Solid Tumor; Carcinoma

Treatments: Drug: ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin

Study type: Interventional

Funder types: Other

Identifiers

NCT06112041

JD-LK2023082-I01

Details and patient eligibility

About

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.

Enrollment: 29 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

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