Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-06 @ 9:54 AM
Study NCT ID:
NCT06417892
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
A Randomized Controlled Study of 2nd-line Treatment of Advanced G/GEJ 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:
RECRUITING
Status Verified Date:
2025-01
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:
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 gastric/gastroesophageal 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 gastric/gastroesophageal junction adenocarcinoma. The study population was pathologically confirmed advanced gastric/gastroesophageal 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 adjuvant/neoadjuvant 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 1:1 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 1:1 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?: