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NCT Number: NCT06112041

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin

Primary outcomes

  1. Objective Response Rate #ORR#

    Time frame: 36 months

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: 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.

  2. Disease control rate (DCR)

    Time frame: 36 months

    DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD).

  3. Overall survival (OS)

    Time frame: 36 months

    OS was defined as the time from the first administration of study treatment to death from any cause.

  4. Adverse event

    Time frame: 36 months

    rate of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Liyuan Zhang, doctor

CONTACT

[email protected]

0512-67784829

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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