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Trial Title:
Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
NCT ID:
NCT05975749
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
Adjuvant treatment
Trastuzuma
Serplulimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
Serplulimab: 4.5mg/Kg on day 1
Arm group label:
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
Intervention type:
Drug
Intervention name:
Trastuzuma
Description:
Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1
Arm group label:
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy
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
Arm group label:
Adjuvant Chemotherapy only
Arm group label:
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
2000000
Country:
China
Status:
Recruiting
Contact:
Last name:
Dazhi Xu, MD,PHD
Phone:
021-64175590
Email:
xudzh@shca.org.cn
Start date:
January 1, 2023
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05975749
