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

NCT05975749 | Recruiting Phase 2

• 1 other identifier: GC-her2
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Adjuvant treatment; Trastuzuma; Serplulimab

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  DFS

  3-year

Secondary Outcomes (2)

• Overall survival

  3-year

• Side effects

  12 months]

Study Arms (2)

Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy

EXPERIMENTAL

Drug: Serplulimab; Drug: Trastuzuma; Drug: Chemotherapy

Adjuvant Chemotherapy only

ACTIVE COMPARATOR

Drug: Chemotherapy

Interventions

Serplulimab DRUG

Serplulimab: 4.5mg/Kg on day 1

Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy

Trastuzuma DRUG

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

Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy

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

Adjuvant Chemotherapy only; Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 2000000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)