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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 | Drug | RC48-ADC combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyuan Zhang, doctor | Contact | 0512-67784829 | zhangliyuan126@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Changchun | China |
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DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD) |
| 24 months |
| Overall survival (OS) | OS was defined as the time from the first administration of study treatment to death from any cause. | 24 months |
| Adverse event | rate of adverse events | 24 months |
| The First People's Hospital of Changzhou | Changzhou | China |
|
| Harbin Medical University Cancer Hospital | Harbin | China |
|
| Jiangyin Peoples Hospital | Jiangyin | China |
|
| Qilu Hospital of Shangdong University | Jinan | China |
|
| Shandong Cancer Hospital | Jinan | China |
|
| The First People's Hospital of Kunshan | Kunshan | China |
|
| Jiangsu Cancer Hospital | Nanjing | China |
|
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | China |
|
| Jiangsu Province Hospital | Nanjing | China |
|
| Nanjing Drum Tower Hospital | Nanjing | China |
|
| Affiliated Hospital of Nantong University | Nantong | China |
|
| The First Hospital of China Medical University | Shenyang | China |
|
| Second Affiliated Hospital of Soochow University | Suzhou | China |
|
| Suzhou Municipal Hospital | Suzhou | China |
|
| The First Affiliated Hospital of Soochow University | Suzhou | China |
|
| Weihai Municipal Hospital | Weihai | China |
|
| Affiliated Hospital of Jiangnan University | Wuxi | China |
|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | China |
|
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
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