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Maintenance therapy is very important in advanced HER-2 negative gastric cancer, and immune monotherapy has no obvious benefit in the first-line maintenance treatment of advanced gastric cancerï¼› Fruquintinib is a potent small-molecule VEGFR inhibitor with high kinase selectivityï¼›Studies have shown that immunotherapy combined with antiangiogenic agents is promising for synergistic antitumor effectsï¼› The aim of this study was to observe and evaluate the efficacy and safety of Fruquintinib combined with PD-1 inhibitor in the first-line maintenance treatment of advanced HER-2 negative gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Fruquintinib+PD-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib+PD-1 | Drug | This is a one-arm, prospective, exploratory clinical study, including patients with advanced HER-2-negative gastric cancer (including gastroesophageal junction adenocarcinoma) who received first-line immunization combined with standard chemotherapy (RECIST 1.1 criteria) and were treated with fruquintinib(4mg orally, once daily for 3 wks on/1 wk off )combined with PD-1 antibody. Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first. PD-1: Nivolumab(360mg IV d1, Q3W);Sintilimab(200mg IV d1, Q3W);Tislelizumab(200mg IV d1, Q3W) can be selected; |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1 | from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1 | from randomization until death due to any cause, assessed up to 3 year |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wu jun | Contact | 13057144311 | wujun68@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Changzhou | Recruiting | Changzhou | Jiangsu | 213004 | China |
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Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1 |
| from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year |
| Disease control rate (DCR) | Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1 | from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year |
| Safety and tolerance evaluated by incidence, severity and outcomes of AEs | Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0 | from first dose to 30 days post the last dose |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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