Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406426
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Study of The Second-line Treatment of Advanced Gastric Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
An Open and Exploratory Study of The Second-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin
Status:
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:
This study is a prospective open-label two-arm exploratory Phase II clinical trial aimed at observing and evaluating the efficacy and safety of combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin as second-line treatment for advanced gastricesophagogastric junction adenocarcinoma Patients meeting the inclusion criteria were divided into two groups based on whether they had received PD-1L1 antibody treatment in the first line Group A immunotherapy-naive group - patients who had previously failed standard chemotherapy in the first line and Group B immunotherapy rechallenge group - patients who had previously failed PD-1L1 antibody combined chemotherapy in the first line All patients received combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin until intolerable toxic reactions occurred disease progression withdrawal of informed consent by the subject loss to follow-up death other conditions judged by the investigator to require termination of treatment or termination of the study whichever occurred first The maximum duration of paclitaxel-albumin treatment was 6 cycles and cadonilimab treatment did not exceed 1 year Clinical tumor imaging evaluations were conducted every 8 weeks during treatment using RECIST v11 criteria and safety assessments were performed using CTCAE 50 recording adverse events within 30 days from the first dose to the end of treatment
Detailed Description:
None
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