NCT07389876

Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ Adenocarcinoma

A Multicenter, Real-world Study on Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multi-cohort real-world research that explores the efficacy and safety of different second-line treatment regimens for gastric/gastroesophageal junction adenocarcinoma that has failed first-line fluoropyrimidine, platinum-based chemotherapy combined with immunotherapy.

Detailed description

Group A (Albumin-bound Paclitaxel Monotherapy Group): Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks. Group B (Albumin-bound Paclitaxel with Anti-angiogenic Therapy Group): Fruquintinib 4 mg/day, once daily orally, on days 1 to 14, every 3 weeks or Ramucirumab 8 mg/kg on days 1 and 15, every 4 weeks; Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks. Group C (Albumin-bound Paclitaxel with Immune Checkpoint Inhibitor Group): Immune checkpoint inhibitor (refer to the drug instructions); Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks. Group D (Albumin-bound Paclitaxel with Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group): Fruquintinib 4 mg/day, once daily orally, on days 1 to 14, every 3 weeks or Ramucirumab 8 mg/kg on days 1 and 15, every 4 weeks; PD-1 200mg d1, Q3W; Albumin-bound paclitaxel: 112.5 mg/m2, i.v. infusion, on days 1 and 8, every 3 weeks. Group E (albumin-bound paclitaxel and trastuzumab emtansine group): Trastuzumab emtansine group (initial dose 800 mg/m2, subsequent doses 600-800 mg/m2); Albumin-bound paclitaxel: 112.5 mg/m2, i.v. infusion, on days 1 and 8, every 3 weeks (only patients with Claudin18.2 positive and who did not receive trastuzumab emtansine in the first-line treatment were included). Treatment continued until disease progression or intolerable toxicity.

Conditions

• Gastric Cancer
• Second-line Treatment

Interventions

Type	Name	Description
DRUG	Albumin-bound Paclitaxel	This is a prospective observational study. We observe efficacy and survival of different treatment regimen.
DRUG	Immune Checkpoint Inhibitor	Immune Checkpoint Inhibitor
DRUG	Anti-angiogenic drug	Anti-angiogenic drug
DRUG	Trastuzumab emtansine	Trastuzumab Emtansine

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: China