ADC Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of HER-2 Positive Advanced Solid Tumors(PRaG3.0)
- Conditions
- Solid TumorCarcinoma
- Interventions
- Drug: ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
- Registration Number
- NCT05115500
- Lead Sponsor
- Second Affiliated Hospital of Soochow University
- Brief Summary
This is an open-label, single-arm, Phase II investigator-initiated trial of antibody-drug conjugate combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory solid tumors with HER-2 positive
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 55
- Aged 18 years and above;
- Diagnosed with histologically or cytologically-confirmed, HER2-positive(IHC 1+, 2+ or 3+), 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;
- T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L；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；
- 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;
- Currently active clinically significant cardiovascular disease such as uncontrolled 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 -
- Primary Outcome Measures
Name Time Method Objective Response Rate （ORR） 24 months Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 24 months OS was defined as the time from the first administration of study treatment to death from any cause.
Disease control rate (DCR) 24 months DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)
Progression-free Survival (PFS) 24 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.
Adverse event 24 months rate of adverse events
Trial Locations
- Locations (19)
The First Bethune Hospital of Jilin University
🇨🇳Changchun, China
Shandong Cancer Hospital
🇨🇳Jinan, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Jiangyin Peoples Hospital
🇨🇳Jiangyin, China
Qilu Hospital of Shangdong University
🇨🇳Jinan, China
The First People's Hospital of Kunshan
🇨🇳Kunshan, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, China
The First Hospital of China Medical University
🇨🇳Shenyang, China
Suzhou Municipal Hospital
🇨🇳Suzhou, China
Weihai Municipal Hospital
🇨🇳Weihai, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, China
Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China
Jiangsu Province Hospital of Chinese Medicine
🇨🇳Nanjing, China
Jiangsu Province Hospital
🇨🇳Nanjing, China