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

Sponsor

Second Affiliated Hospital of Soochow University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06112041

Collaborator

(none)

Enrollment

Location

Arm

36.2

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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 patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Solid Tumor	Drug: ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 25, 2023

Anticipated Primary Completion Date :

Oct 30, 2026

Anticipated Study Completion Date :

Oct 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin	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

Arm

Intervention/Treatment

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

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

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

Outcome Measures

Primary Outcome Measures

Objective Response Rate #ORR# [36 months]
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

Secondary Outcome Measures

Progression-free Survival (PFS) [36 months]
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.
Disease control rate (DCR) [36 months]
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD).
Overall survival (OS) [36 months]
OS was defined as the time from the first administration of study treatment to death from any cause.
Adverse event [36 months]
rate of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts 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) ≤3.0ULN, or AST and ALT≤5ULN 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital of Soochow University	Suzhou		China

Sponsors and Collaborators

Second Affiliated Hospital of Soochow University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital of Soochow University

ClinicalTrials.gov Identifier:

NCT06112041

Other Study ID Numbers:

JD-LK2023082-I01

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Thymopentin

Study Results

No Results Posted as of Nov 1, 2023