Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669496
Status:
RECRUITING
Last Update Posted:
2021-07-07
First Post:
2020-12-14
Brief Title:
Phase II-III Clinical Trial of PD1 Antibody Toripalimab Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
A Randomized Controlled Multicenter Open Seamless Phase II-III Clinical Trial of PD1 Antibody Toripalimab Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
Status:
RECRUITING
Status Verified Date:
2020-12
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:
A randomized controlled multicenter open seamless phase II-III clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors which has extremely low postoperative recurrence-free survival In this study we aim to compare the prognosis in intrahepatic cholangiocarcinoma between Toripalimab combined with leventinib and GEMOX neoadjuvant treatment and the current clinical surgical treatment traditional group
Detailed Description:
Intrahepatic cholangiocarcinoma ICC is a malignant tumor of biliary epithelial cells that originates from the branches of the intrahepatic bile duct at the second level and above Its incidence accounts for about 15-20 of primary liver malignancies showing a gradual increase trend Surgical resection is currently the main method for the treatment of ICC The data of a large number of ICC cases shows that even radical resection R0 patients have an average survival of only 183 months while for palliative resection patients the average survival is only 66 months and laparotomy patients only 56 months Retrospective studies reported that positive resection margins lymph node metastasis lymphatic vessel invasion nerve bundle invasion preoperative CA199200Uml multiple tumor nodules and differentiation are the main factors affecting the survival of ICC patients after surgery How to improve the surgical results of ICC patients especially those with high risk factors for postoperative recurrence is an important way to improve the overall survival of ICC Neoadjuvant therapy refers to some treatments taken before surgery for newly treated tumor patients who have not found distant metastasis including chemotherapy radiotherapy targeted therapy etc to reduce tumors reduce tumor stages and reduce postoperative recurrence rate prolonging survival time Our previous study using Toripalimab combined with lenvatinib and Gemox chemotherapy in the first-line treatment of unresectable advanced cholangiocarcinoma NCT039515972020ESMO showed that the ORR was 80 and the DCR reached 933 of which 1 case was CR 23 cases were PR and 2 cases were successfully treated with radical resection after downstage And the adverse reactions are controllable These data suggest that Toripalimab combined with lenvatinib and Gemox chemotherapy may be an ideal neoadjuvant treatment for patients with resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors needing more investigation
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