Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447636
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in GastricGastroesophageal Junction Adenocarcinoma
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma the Phase 2 Solids-01 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For locally advanced gastric and gastroesophageal junction adenocarcinoma cT3-4bNanyM0 perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage increase the R0 resection rate and may improve the long-term survival Combination of perioperative surufatinib sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy Surufatinib as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor VEGFR1 23 fibroblast growth factor receptor 1FGFR1 and colony stimulating factor 1 receptor CSF1R It is a proprietary product developed by Hutchison Whampoa Pharmaceutical Shanghai China Co LTD Surufatinib has been approved for neuroendocrine tumor This study is a monocenter single-arm phase 2 clinical trial to evaluate tolerability safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma
Detailed Description:
The incidence of gastric and gastroesophageal junction adenocarcinoma is increasing in China and it is one of the most common malignant tumors in China Surgery is the only possible way to cure gastric and gastroesophageal junction adenocarcinoma however over 70-80 of gastricgastroesophageal junction adenocarcinoma patients in China are in advanced stage Locally gastricgastroesophageal junction adenocarcinoma cT3-4bNanyM0 could be cured by multi-disciplinary therapies including surgery immunotherapy and chemotherapy Perioperative immunotherapy plus chemotherapy can downstage tumor T and N stage increase the R0 resection rate and may improve the long-term survival However the therapeutic effects still not satisfactory to date Surufatinib as the novel oral antivascular targeting drug has been proved to be effective in neuroendocrine tumor Combination of perioperative surufatinib and immunotherapy plus chemotherapy for locally advanced gastricgastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy This study is a monocenter single-arm phase 2 clinical trial to evaluate tolerability safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None