Study of Fruquintinib and Albumin-paclitaxel With or Without PD-1 Antibody for Second-Line Treatment of Advanced Gastric/Gastroesophageal Junction Adenocarcinoma in Patients Previously Treated with PD-1 Antibody

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining fruquintinib and albumin-paclitaxel with or without a PD-1 antibody for patients with advanced gastric or gastroesophageal junction adenocarcinoma who have not responded to prior anti-PD-1 or PD-L1 treatments. This study focuses on second-line treatment for patients who have already undergone one systemic therapy including immune drugs. The goal is to explore new treatment options in a randomized controlled setting. Participants will be randomly assigned to one of two treatment groups: one receiving fruquintinib combined with albumin-paclitaxel, and the other receiving the same combination plus a PD-1 monoclonal antibody. A total of 60 subjects will be enrolled, with 30 in each group. The PD-1 antibody used will be selected based on the patient's first-line treatment history. Treatment administration and follow-up visits will be conducted according to clinical norms without a fixed schedule. During the study, physicians will collect baseline demographic and disease information before treatment starts. Treatment-related data, including side effects and tumor status, will be gathered during follow-up visits. After the study ends, survival follow-up will occur every three months through phone calls, messaging apps, or communication with other doctors. Key outcomes such as progression-free survival over two years will be measured, with ongoing monitoring for patient safety and study completion criteria including death, withdrawal, or loss of follow-up.

Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma