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First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

NCT06730373 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-12-31

No results posted yet for this study

Summary

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions

  • HER2-positive Gastric Cancer
  • Metastatic Gastric Cancer
  • Unresectable Gastric Carcinoma

Interventions

DRUG

Disitamab Vedotin

2.5 mg/kg IV every 3 weeks

DRUG

Sintilimab

200 mg IV every 3 weeks

DRUG

S-1

40-60 mg BID for 14 days, every 3 weeks

DRUG

Trastuzumab

First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks

DRUG

Oxaliplatin

130 mg/m2 Q3W

DRUG

Capecitabine

1000 mg/m² Q3W

DRUG

5-FU

800 mg/m²

DRUG

Cisplatin

80 mg/m²

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Lian Liu, MD · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-10-17
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06730373 on ClinicalTrials.gov