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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05975749

Enrollment

114

Registered

2023-08-04

Start date

2023-01-01

Completion date

2029-01-01

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric Cancer, Adjuvant treatment, Trastuzuma, Serplulimab

Brief summary

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.

Interventions

DRUGSerplulimab

Serplulimab: 4.5mg/Kg on day 1

DRUGTrastuzuma

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

DRUGChemotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Lower age limit of research subjects 20 years old and upper age limit of 80 years old. 2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences 3. R0 gastrectomy with D2 lymphadenectomy 4. Her2+ diagnosed by Immunohistochemistry or FISH 5. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months 6. 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

1. Patients with stage I and IV. 2. Unavailable for R0 resection and D2 lymph node dissection. 3. Multiple primary tumors 4. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases. 5. History of chemotherapy, radiotherapy, immunotherapy or target therapy.

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	3-year	DFS

Secondary

Measure	Time frame	Description
Overall survival	3-year	OS
Side effects	12 months]	Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026