Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05241899
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-02-16
First Post:
2022-02-06
Brief Title:
A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction GGEJ Cancer
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
A Multicenter Open LabelSingle ArmPhase II Study to Evaluate the Effect and Safety Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction GGEJ Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-02
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:
Although Pembrolizumab plus trastuzumab and chemotherapy is the standard of care for first-line treatment of HER2-positive advanced or metastatic gastric or gastroesophageal junction GGEJ cancerthere is no established therapy in the second-line setting
RC48 showed promising activity with manageable safety in patients with HER2-overexpressing advanced GGEJ cancer who have previously received at least two lines of chemotherapyFruquintinib in combination with Paclitaxel demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b2 study
This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GGEJ cancer
RC48 showed promising activity with manageable safety in patients with HER2-overexpressing advanced GGEJ cancer who have previously received at least two lines of chemotherapyFruquintinib in combination with Paclitaxel demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b2 study
This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GGEJ cancer
Detailed Description:
This study is a phase II single arm study with main purpose to evaluate the safety tolerability and efficacy of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GGEJ cancer
All eligible patients received Fruquintinib 4mg orally once daily for 3 wks on1 wk off combined with of RC48 25mgkg by intravenous infusion during 30-90 min every 2 weeks until investigator assessed loss of clinical benefit unacceptable toxicity investigator or participant decision to withdraw from therapy or death whichever occurs first
All eligible patients received Fruquintinib 4mg orally once daily for 3 wks on1 wk off combined with of RC48 25mgkg by intravenous infusion during 30-90 min every 2 weeks until investigator assessed loss of clinical benefit unacceptable toxicity investigator or participant decision to withdraw from therapy or death whichever occurs first
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