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

S

Soochow University

Status and phase

Not yet enrolling
Phase 2

Conditions

Solid Tumor
Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06112041
JD-LK2023082-I01

Details and patient eligibility

About

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.

Enrollment

29 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No 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) ≤3.0*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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

29 participants in 1 patient group

ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
Experimental group
Description:
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
Treatment:
Drug: ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin

Trial contacts and locations

1

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Central trial contact

Liyuan Zhang, doctor

Data sourced from clinicaltrials.gov

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