The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
NCT ID: NCT06112041
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
29 participants
INTERVENTIONAL
2023-10-25
2026-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin
Interventions
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ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Locations
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Second Affiliated Hospital of Soochow University
Suzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JD-LK2023082-I01
Identifier Type: -
Identifier Source: org_study_id
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