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

NCT06385873 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-13

No results posted yet for this study

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.

Conditions

  • Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Interventions

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);

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Xiaofeng Xiaofeng, Ph.D · The First Affiliated Hospital with Nanjing Medical University

  • Hao Xu, Ph.D · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2027-05-01
Completion
2028-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06385873 on ClinicalTrials.gov