Not yet recruiting NCT06112041
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin.
- Who it may be relevant to
- Registry conditions: Carcinoma, Solid Tumor. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors(PRaG9.0)
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- Objective Response Rate #ORR# [Time frame: 36 months]
Secondary outcome measures (4)
- Progression-free Survival (PFS) [Time frame: 36 months]
- Disease control rate (DCR) [Time frame: 36 months]
- Overall survival (OS) [Time frame: 36 months]
- Adverse event [Time frame: 36 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital of Soochow University — Suzhou
Publications
- Zhao X, Yang M, Zhang J, Kong Y, Xu M, Chen R, Yin Q, Wang S, Chen G, Xing P, Zhang L. Efficacy and Safety of PRaG Therapy in Elderly Patients with Advanced Malignant Tumors: A Prospective, Multicenter Clinical Study Protocol (PRaG 9.0 Study). Technol Cancer Res Treat. 2025 Jan-Dec;24:15330338251400412. doi: 10.1177/15330338251400412. Epub 2025 Nov 27. PMID 41308040
Identifiers
NCT: NCT06112041 · JD-LK2023082-I01