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

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05975749

Collaborator

(none)

114

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Serplulimab Drug: Trastuzuma Drug: Chemotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy	Drug: Serplulimab Serplulimab: 4.5mg/Kg on day 1 Drug: Trastuzuma Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1 Drug: Chemotherapy 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
Active Comparator: Adjuvant Chemotherapy only	Drug: Chemotherapy 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

Arm

Intervention/Treatment

Experimental: Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy

Drug: Serplulimab

Serplulimab: 4.5mg/Kg on day 1

Drug: Trastuzuma

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

Drug: Chemotherapy

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

Active Comparator: Adjuvant Chemotherapy only

Drug: Chemotherapy

Outcome Measures

Primary Outcome Measures

Disease-free survival [3-year]
DFS

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	2000000

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dazhi Xu, Professor, Fudan University

ClinicalTrials.gov Identifier:

NCT05975749

Other Study ID Numbers:

GC-her2

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 4, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dazhi Xu, Professor, Fudan University

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Aug 4, 2023