To hear about similar clinical trials, please enter your email below
Trial Title:
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
NCT ID:
NCT06112041
Condition:
Carcinoma
Solid Tumor
Conditions: Official terms:
Neoplasms
Thymopentin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
Description:
RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF
and Thymopentin
Arm group label:
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
75 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Contact:
Last name:
Liyuan Zhang, doctor
Phone:
0512-67784829
Email:
zhangliyuan126@126.com
Start date:
October 25, 2023
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Second Affiliated Hospital of Soochow University
Agency class:
Other
Source:
Second Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06112041
