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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Serplulimab
Trastuzuma
Chemotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Adjuvant treatment, Trastuzuma, Serplulimab

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy

Adjuvant Chemotherapy only

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival
DFS

Secondary Outcome Measures

Overall survival
OS
Side effects
Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder

Full Information

First Posted
July 27, 2023
Last Updated
July 27, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05975749
Brief Title
Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Adjuvant treatment, Trastuzuma, Serplulimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Treatment od Serplulimab and Trastuzuma and Chemotherapy
Arm Type
Experimental
Arm Title
Adjuvant Chemotherapy only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Serplulimab
Intervention Description
Serplulimab: 4.5mg/Kg on day 1
Intervention Type
Drug
Intervention Name(s)
Trastuzuma
Intervention Description
Trastuzuma: 8mg/Kg ( the first cycle),6mg/Kg (the rest of cycles) on day 1
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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 Outcome Measure Information:
Title
Disease-free survival
Description
DFS
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Overall survival
Description
OS
Time Frame
3-year
Title
Side effects
Description
Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder
Time Frame
12 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
2000000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dazhi Xu, MD,PHD
Phone
021-64175590
Email
xudzh@shca.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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