Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the HER-2 Positive GC/GEJC

Sponsor
The First Affiliated Hospital of Zhengzhou University
Study ID
NCT06439550
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • HER2-positive Gastric Cancer

Eligibility Criteria

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

Interventions

  • Serplulimab — DRUG
    300mg, q3w
  • Trastuzumab — DRUG
    First dose 8mg/kg, maintenance 6mg/kg, q3w
  • Oxaliplatin + Tegafur — DRUG
    oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w).

Study Details

This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab，Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC)

Key Dates

Start date
Jul 15, 2024
Status verified
Nov 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Serplulimab，Trastuzumab and SOX
    Within 4 weeks after surgery, patients will be enrolled in the study and started on Serplulimab (300mg, q3w) + Trastuzumab (First dose 8mg/kg, maintenance 6mg/kg, q3w) + oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w). Among them, oxaliplatin + Teggio can be used for 4-6 cycles according to the patient's tolerance, and Serplulimab + trastuzumab can be continued until 12 months or tumor recurrence or metastasis

Primary Outcome Measure

Disease progression free survival （DFS） [ Time Frame: 24 months after the last subject participating in ]

Central Contacts

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