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

ConditionHER2-positive Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed gastric adenocarcinoma/esophagogastric junction adenocarcinoma, HER-3 + or HER-2 +, with Fish amplification;

Subjects must complete R0 resection before enrollment；If they received neoadjuvant therapy, it was required that the neoadjuvant therapy regimen should not contain anti-HER-2 targeted drugs;

Postoperative pathology: II-III;

Age 18-75 years old;

Disqualifiers

A history of any other malignancy in the past 5 years (except carcinoma in situ or basal cell carcinoma of the skin or squamous cell carcinoma of the skin)；Patients with small gastric stromal tumors and other tumors may be excluded if the researcher determines that other tumors will not affect the patient's life in the short term；

Participated in clinical trials of other drugs within four weeks;

Have any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects has vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included)

Requires systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration to treat a current condition.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Serplulimab，Trastuzumab and SOXExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Disease progression free survival （DFS）

Objective response rate according to RECIST 1.1

Time frame
24 months after the last subject participating in

Secondary outcomes

1

Overall survival (OS）

Overall survival

Time frame
24 months after the last subject participating in
2

Recurrence rate

Objective response rate according to RECIST 1.1

Time frame
24 months after the last subject participating in
3

Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE

Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE

Time frame
through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: