NCT06475417

Neoadjuvant Adebrelimab + DOS in Locally Advanced Resectable Gastric Cancer

Phase II Study of Neoadjuvant Adebrelimab, Docetaxel, Oxaliplatin, and S-1 in Patients With Resectable Advanced Gastric Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of adebrelimab combined DOS in neoadjuvant treatment of locally advanced resectable gastric cancer.

Detailed description

This prospective, single-center, single-arm clinical trial aims to enroll 42 treatment-naïve patients diagnosed with locally advanced gastric adenocarcinoma who are deemed operable. Following informed consent, patients will undergo screening to confirm eligibility. Subsequently, eligible participants will receive the standard dosage of Adebrelimab in combination with the DOS regimen for three cycles as neoadjuvant therapy prior to surgery. Within 3-6 weeks after completing the third cycle, preoperative imaging will be conducted to assess the efficacy of the novel neoadjuvant treatment and feasibility of achieving radical D2 resection. Patients will then undergo radical surgical resection for gastric cancer, with pathological complete response (pCR) being observed.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab combined with DOS	After signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of adebrelimab combined with DOS regimen for 3 courses of treatment before surgery, and within 3-6 weeks after the completion of the third administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient underwent radical surgical treatment for gastric cancer and observed pCR

Timeline

• Start date: 2024-05-24
• Primary completion: 2025-05-20
• Completion: 2026-04-26
• First posted: 2024-06-26
• Last updated: 2024-06-26

Locations

1 site across 1 country: China