NCT06464601

A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Gastric Cancer

A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Gastric Cancer With Chemotherapy Combined With Immune Checkpoint Inhibitors and Anti-Angiogenic Targeted Agents

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Chemotherapy, immune checkpoint inhibitors, and anti-angiogenic targeted therapies have been explored in combination for neoadjuvant and conversion therapies. However, the efficacy of the novel anti-angiogenic agent fruquintinib in combination with immune checkpoint inhibitors and chemotherapy in the neoadjuvant and conversion treatment of locally advanced or metastatic gastric cancer has not been reported. This study aims to observe the efficacy and safety of fruquintinib combined with immune checkpoint inhibitors and chemotherapy in real-world settings.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	fruquintinib combined with immune checkpoint inhibitors and chemotherapy	Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: XELOX or SOX. Immune Checkpoint Inhibitors: Selection based on clinical guidelines/indications and patient condition, including but not limited to PD-1 inhibitors, PD-L1 inhibitors. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.
COMBINATION_PRODUCT	fruquintinib combined with immune checkpoint inhibitors and chemotherapy	Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: XELOX or SOX. Immune Checkpoint Inhibitors: Selection based on clinical guidelines/indications and patient condition, including but not limited to PD-1 inhibitors, PD-L1 inhibitors. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-03-31
• Completion: 2027-03-31
• First posted: 2024-06-18
• Last updated: 2024-06-18

Locations

1 site across 1 country: China