Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102746
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-18
Brief Title:
Clinical Study of Surufatinib Plus Sintilimab Combined With Chemotherapy in the Treatment of Advanced Gastric Neuroendocrine Carcinoma
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Single-center Open Phase II Clinical Study of Surufatinib Plus Sintilimab Combined With Chemotherapy in the Treatment of Advanced Gastric Neuroendocrine Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This study aims to explore whether the combination of surufatinib anti-angiogenic therapy and sintilimab PD-1 inhibitor on the basis of EP regimen can further improve the effective rate and survival time of first-line treatment for patients with advanced gastric neuroendocrine carcinoma and explore the safety and tolerability of this regimen
Detailed Description:
In this study patients with advanced gastric neuroendocrine carcinoma were selected as the research object Based on the standard EP regimen the combination of surufatinib anti-angiogenic therapy and sintilimab PD-1 inhibitor could further improve the effective rate and survival time of patients and explore the safety and tolerability of this treatment regimen
Patients with advanced gastric neuroendocrine carcinoma who have not received systematic treatment will be treated with the following protocols
Sintilimab 200mg intravenously administered on day 1 Surufatinib 200mg day orally taken continuously Etoposide 1 2 3 days of continuous administration 100mgm2 intravenous infusion Cisplatin 75mgm2 on day 1 or 25mgm2 on day 1 2 and 3 intravenous infusion One treatment cycle every 21 days Etoposide and cisplatin were used for a maximum of 4 cycles after which maintenance therapy of solantinib and sindellizumab was administered and the longest treatment cycle was 13 cycles a total of 1 year Patients received regular and periodic reviews and imaging assessments were performed every 6 weeks after enrollment in the study Safety will be evaluated by AE and laboratory tests After disease progression all patients were followed up with their secondary survival status every 3 months until death
Patients with advanced gastric neuroendocrine carcinoma who have not received systematic treatment will be treated with the following protocols
Sintilimab 200mg intravenously administered on day 1 Surufatinib 200mg day orally taken continuously Etoposide 1 2 3 days of continuous administration 100mgm2 intravenous infusion Cisplatin 75mgm2 on day 1 or 25mgm2 on day 1 2 and 3 intravenous infusion One treatment cycle every 21 days Etoposide and cisplatin were used for a maximum of 4 cycles after which maintenance therapy of solantinib and sindellizumab was administered and the longest treatment cycle was 13 cycles a total of 1 year Patients received regular and periodic reviews and imaging assessments were performed every 6 weeks after enrollment in the study Safety will be evaluated by AE and laboratory tests After disease progression all patients were followed up with their secondary survival status every 3 months until death
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