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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06112041
Other study ID # JD-LK2023082-I01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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