NCT06385873

RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer

Disitamab Vedotin Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer With HER2 Overexpression: a Prospective, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Detailed description

The study plans to enroll 32 subjects. After signing the informed consent form and meeting the inclusion and exclusion criteria, patients will receive standard-dose treatment of the RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery. Apatinib will only be used for 14 days in the last cycle. Imaging studies will be conducted 3-4 weeks after the last dose to assess the efficacy of neoadjuvant therapy and the possibility of radical D2 gastrectomy. The treatment plan after curative surgery for gastric cancer will be determined by the investigators and the patients based on the pathological findings. Patients who benefit clinically after surgery may receive adjuvant therapy with RC48, Adebrelimab, Apatinib and S-1 for 4 cycles (the first treatment is expected to start around 4 weeks after surgery) or follow the standard postoperative adjuvant regimen recommended by the guidelines.

Conditions

• Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	RC48	RC48: 2.5 mg/kg, intravenous infusion, on day 1, every 3 weeks (Q3W);
DRUG	Adebrelimab	Adebrelimab：1200 mg, intravenous infusion, on day 1, every 3 weeks (Q3W);
DRUG	Apatinib	Apatinib: 250mg, oral administration, once daily (qd), every 3 weeks (Q3W);
DRUG	S-1	S-1：For patients with a body surface area (BSA) ≤1.5m², use 50mg each time; for patients with BSA \>1.5m², use 60mg each time, oral administration, twice daily (bid), on days 1-14, every 3 weeks (Q3W);

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2024-04-26
• Last updated: 2024-05-13