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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112041
• Other study ID #: JD-LK2023082-I01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 25, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital of Soochow University
• Contact: Liyuan Zhang, doctor
• Phone: 0512-67784829
• Email: zhangliyuan126[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 29
• Est. completion date: October 30, 2026
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Soochow University	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate #ORR#	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).	36 months
Secondary	Progression-free Survival (PFS)	PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.	36 months
Secondary	Disease control rate (DCR)	DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD).	36 months
Secondary	Overall survival (OS)	OS was defined as the time from the first administration of study treatment to death from any cause.	36 months
Secondary	Adverse event	rate of adverse events	36 months