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

NCT06112041 | Not Yet Recruiting Phase 2

• 1 other identifier: JD-LK2023082-I01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free Survival (PFS)

  36 months

• Disease control rate (DCR)

  36 months

• Overall survival (OS)

  36 months

• Adverse event

  36 months

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

Second Affiliated Hospital of Soochow University

Suzhou, China

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Carcinoma

Interventions

Radiotherapy; Thymopentin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Thymopoietins; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Liyuan Zhang, doctor

CONTACT

0512-67784829; zhangliyuan126@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

CN (1)