NCT05627414

Conversion Therapy of Disitamab Vedotin Combined With Sintilimab and S-1 in HER2 Overexpression Gastric Cancer

Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab and S-1 in the Conversion Treatment of HER2 Overexpression Unresectable Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, one-arm study, which is aiming to evaluate the feasibility of combination of Disitamab Vedotin, Sintilimab and S-1 as conversion therapy in patients with HER2 overexpression unresectable gastric cancer .

Detailed description

In this study, 30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions). During the study, safety evaluation and effectiveness evaluation will be conducted.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	2.5mg/kg，IV，Q3W
DRUG	Sintilimab	200 mg，IV，Q3W
DRUG	S-1	40\~60mg / m2, bid, d1-14, repeated every 3 weeks.
PROCEDURE	Intraperitoneal chemotherapy with paclitaxel	Paclitaxel (PTX) was used with a dose of 60mg / m2, Q3W. （Only for patients with peritoneal metastases）

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-06-01
• Completion: 2025-01-01
• First posted: 2022-11-25
• Last updated: 2022-11-25