Status:
NOT_YET_RECRUITING
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Carcinoma
Solid Tumor
Eligibility:
All Genders
75+ years
Phase:
PHASE2
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06112041
Start Date
October 25 2023
End Date
October 30 2026
Last Update
November 1 2023
Active Locations (1)
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1
Second Affiliated Hospital of Soochow University
Suzhou, China