NCT07330063

Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection. Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.

Conditions

• Gastrectomy

Interventions

Type	Name	Description
DRUG	Anruikefen (Intravenous Bolus)	Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
DRUG	Anruikefen (Intravenous Infusion)	Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
DRUG	Placebo Group	Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China