Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04443309
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2020-06-21
Brief Title:
Lenvatinib in Combination With Camrelizumab as First-Line Therapy in Patients With Advanced HCC
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Single-arm Non-randomized Single-center Study to Evaluate Lenvatinib in Combination With Camrelizumab as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-01
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 is a single arm open-label non-randomized and single-center phase III clinical study to evaluate the the safety tolerance and efficacy of Lenvatinib plus Camrelizumab as first-line therapy in patients with advanced Hepatocellular Carcinoma
Detailed Description:
The purpose of this study is to evaluate the safety tolerance and efficacy of Lenvatinib combined with Camrelizumab as first-line therapy for patients with advanced hepatocellular carcinomaThe target sample size is 53In the first phase 6 panticipants was evaluated N33 If there was no obvious dose-limiting toxicity DLT then entered the extended phase N47Treatment continually until disease progression or intolerable toxicity or patients withdrawal of consent
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