Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05975749

Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer

The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 2000000, China

Location status: Recruiting

Location contact

Dazhi Xu, MD,PHD

CONTACT

[email protected]

021-64175590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lower age limit of research subjects 20 years old and upper age limit of 80 years old.
  • Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
  • R0 gastrectomy with D2 lymphadenectomy
  • Her2+ diagnosed by Immunohistochemistry or FISH
  • ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
  • No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).

Exclusion criteria

  • Patients with stage I and IV.
  • Unavailable for R0 resection and D2 lymph node dissection.
  • Multiple primary tumors
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
  • History of chemotherapy, radiotherapy, immunotherapy or target therapy.

Treatment and study plan

Serplulimab

Drug

Serplulimab: 4.5mg/Kg on day 1

Trastuzuma

Drug

Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1

Chemotherapy

Drug

Chemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease

Primary outcomes

  1. Disease-free survival

    Time frame: 3-year

    DFS

Secondary outcomes

  1. Overall survival

    Time frame: 3-year

    OS

  2. Side effects

    Time frame: 12 months]

    Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Aug 4, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.