Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-13
Brief Title:
Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of GGEJ Adenocarcinoma
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
A Randomized Controlled Study of 2nd-line Treatment of Advanced GGEJ Adenocarcinoma With Fruquintinib and Albumin-paclitaxel in Combination With or Without PD-1 Antibody in Patients Who Have Failed Treatment With PD-1 Antibody
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastricgastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 PD-L1 regimen
Detailed Description:
This is a single-center prospective open randomized controlled study of patients with advanced second-line gastricgastroesophageal junction adenocarcinoma The study population was pathologically confirmed advanced gastricgastroesophageal junction adenocarcinoma which had undergone one systemic treatment First-line exposure to immune drugs including PD-1 drug exposure at the stage of neoadjuvant adjuvant and systemic therapy For patients with metastasis and recurrence within 6 months after the end of adjuvantneoadjuvant system treatment the above-mentioned treatment is first-line treatment After patients meeting the inclusion criteria signed informed consent the study was observed from the start of treatment until death withdrawal of informed consent loss of follow-up or the end of the study
Eligible subjects will be randomly assigned to either fruquintinib combined with albumin-paclitaxel or fruquintinib combined with albumin-paclitaxel combined with PD-1 monoclonal antibody in a 11 ratio A total of 60 subjects are planned to enter the study treatment 30 in each treatment group and enter one of the following open treatment groups
Group A Fruquintinib combined with albumin-paclitaxel regimen Group B Fruquintinib albumin-paclitaxel combined with PD-1 antibody regimen For enrolled patients the treating physician conducted the first visit before treatment and the follow-up visit and the last visit after treatment began Visits were conducted in accordance with clinical norms and there was no fixed schedule for visits Physicians collect demographic and disease-related baseline data from medical records or at the first visit prior to treatment Treatment-related data including adverse events and tumor status were collected during follow-up visits Survival follow-up was conducted every 3 months after the end of the study either by phone wechat or through other doctors The last visit recorded patient death withdrawal of informed consent loss of visit or end of study
Eligible subjects will be randomly assigned to either fruquintinib combined with albumin-paclitaxel or fruquintinib combined with albumin-paclitaxel combined with PD-1 monoclonal antibody in a 11 ratio A total of 60 subjects are planned to enter the study treatment 30 in each treatment group and enter one of the following open treatment groups
Group A Fruquintinib combined with albumin-paclitaxel regimen Group B Fruquintinib albumin-paclitaxel combined with PD-1 antibody regimen For enrolled patients the treating physician conducted the first visit before treatment and the follow-up visit and the last visit after treatment began Visits were conducted in accordance with clinical norms and there was no fixed schedule for visits Physicians collect demographic and disease-related baseline data from medical records or at the first visit prior to treatment Treatment-related data including adverse events and tumor status were collected during follow-up visits Survival follow-up was conducted every 3 months after the end of the study either by phone wechat or through other doctors The last visit recorded patient death withdrawal of informed consent loss of visit or end of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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