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This is a prospective multicenter clinical study to determine the efficacy and safety of hypofractionated radiotherapy combined with PD-1 inhibitor sequential GM-CSF and IL-2 for advanced multiple metastatic solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT+PD-1+GM-CSF+IL-2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | 10-24Gy/5-8Gy/2-3f |
| |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival,PFS | Time from cycle 1, day 1 of treatment to disease progression or death due to any cause | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate,ORR | The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1. | Up to 3 years |
| Disease control rate,DCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyuan Zhang, Dr | Contact | 0086-0512-67784827 | zhangliyuan126@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liyuan Zhang, Dr | Second Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Not yet recruiting | Beijing | China |
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| PD-1 inhibitor |
| Drug |
q3w, until PD |
|
| GM-CSF | Drug | 200μg, D1-D7, ≥8 cycles |
|
| IL-2 | Drug | at a dose of 2 million IU, D8-D14, ≥8 cycles |
|
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) or stable disease (SD) using RECIST v1.1.
| Up to 3 years |
| Overall survival,OS | Time from cycle 1, day 1 of treatment until death due to any cause | Up to 3 years |
| Hunan Cancer Hospital | Not yet recruiting | Changsha | China |
|
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | China |
|
| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | China |
|
| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | China |
|
| The Sixth Affiliated Hospital ,Sun Yat-seen University | Not yet recruiting | Guangzhou | China |
|
| Cancer Hospital of The University of Chinese Academy of Sciences | Recruiting | Hangzhou | China |
|
| The First Affiliated Hospital of USTC | Recruiting | Hefei | China |
|
| Shandong Provincial Tumor Hospital | Not yet recruiting | Jinan | China |
|
| The Second Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | China |
|
| Jiangsu Cancer Hospital | Not yet recruiting | Nanjing | China |
|
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | China |
|
| Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | China |
|
| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | China |
|
| Jiangyin People's Hospital | Recruiting | Wuxi | China |
|
| The Affilated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | China |
|
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D000082082 | Immune Checkpoint Inhibitors |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007378 | Interleukins |
| D008222 | Lymphokines |
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