Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361030
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-01
Brief Title:
Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
An Exploratory Clinical Study of Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Patients With Locally Advanced Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer
Detailed Description:
Pancreatic ductal adenocarcinoma PDAC has a very poor prognosis Currently there is no standard treatment for locally unresectable PDAC and clinical research and conversion therapy are encouraged by guidelines Whether it is conversion or palliative chemotherapy in fact the choice of chemotherapy is based on the existing first-line regimens of metastatic PDCA Gemcitabine combined with nab-paclitaxel is one of the preferred first-line chemotherapy regimens for metastatic or locally advanced PDAC However the conversion rate of gemcitabine combined with nab-paclitaxel is not ideal according to the current results The aim of this study is to investigate whether the combination of gemcitabine and nab-paclitaxel with surufatinib can improve the surgical conversion rate
This is a prospective single-arm exploratory clinical study A safety run-in period of 6 patients will be set After 4-6 cycles of induction therapy with gemcitabine and nab-paclitaxel plus surufatinib if become operable the therapy will be continued for another 6 months after surgery if not operable the therapy will be also continued as long as no PD during induction therapy If PD occurs it will enter second-line therapy Surufatinib capsule will be administered orally 200mg once daily a 4-week treatment cycleQ4W during combined with gemcitabine and nab-paclitaxel If all chemotherapy drugs are stopped during the maintenance treatment period and only surufatinib is left the dose of surufatinib can be increased to 300 mg per dose according to the patients condition Gemcitabine and nab-paclitaxel plus surufatinib will be used until disease progression death intolerable toxicity initiation of new antineoplastic therapy withdrawal of informed consent loss of follow-up and other conditions that require treatment discontinuation or the study is completed Whichever comes first If surgical resection was performed it will be maintained for 6 months
This is a prospective single-arm exploratory clinical study A safety run-in period of 6 patients will be set After 4-6 cycles of induction therapy with gemcitabine and nab-paclitaxel plus surufatinib if become operable the therapy will be continued for another 6 months after surgery if not operable the therapy will be also continued as long as no PD during induction therapy If PD occurs it will enter second-line therapy Surufatinib capsule will be administered orally 200mg once daily a 4-week treatment cycleQ4W during combined with gemcitabine and nab-paclitaxel If all chemotherapy drugs are stopped during the maintenance treatment period and only surufatinib is left the dose of surufatinib can be increased to 300 mg per dose according to the patients condition Gemcitabine and nab-paclitaxel plus surufatinib will be used until disease progression death intolerable toxicity initiation of new antineoplastic therapy withdrawal of informed consent loss of follow-up and other conditions that require treatment discontinuation or the study is completed Whichever comes first If surgical resection was performed it will be maintained for 6 months
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