NCT05625737

Fruquintinib Combined with Sintilimab As Second-line Therapy for Gastric or Gastro-esophageal Junction Adenocarcinoma

A Single-center, Single-arm, Open-label, Exploratory Study Evaluating Fruquintinib Combined with Sintilimab in Second-line Treatment of Patients with Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a single-arm, prospective study to investigate the efficacy and safety of fruquintinib combined with sintilimab in the second-line treatment of Chinese patients with advanced gastric/GEJ adenocarcinoma.

Detailed description

Patients with adenocarcinoma of the gastro-esophageal junction or the stomach who have documented progression after being treated with a 1st line chemotherapy can be included. All patients will receive a second line therapy with fruquintinib and sintilimab, a checkpoint inhibitor. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib will be administrated as 4mg orally, once daily for 2 weeks on/1 week off.
DRUG	Sintilimab	Sintilimab will be administrated as 200mg once every 3 weeks.

Timeline

• Start date: 2022-09-08
• Primary completion: 2024-12-01
• Completion: 2025-09-01
• First posted: 2022-11-23
• Last updated: 2024-09-19

Locations

1 site across 1 country: China