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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06385873
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RC48 — DRUG
    RC48: 2.5 mg/kg, intravenous infusion, on day 1, every 3 weeks (Q3W);
  • Adebrelimab — DRUG
    Adebrelimab：1200 mg, intravenous infusion, on day 1, every 3 weeks (Q3W);
  • Apatinib — DRUG
    Apatinib: 250mg, oral administration, once daily (qd), every 3 weeks (Q3W);
  • S-1 — DRUG
    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);

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
May 2024
Primary completion
May 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery.

Primary Outcome Measure

Pathological Complete Response Rate (pCR) [ Time Frame: 4 months ]

Central Contacts