About this trial
The goal of this clinical trial is to learn if treatment modality including Disitamab Vedotin (RC48), Oxaliplatin,Tegafur,Gimeracil and Oteracil Porassium Capsules (SOX)and Sindillimab works to treat locally advanced hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are:
* To evaluate the perioperative efficacy of RC48 combined with sindillizumab and SOX in the treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of RC48 combined with sindillizumab and SOX regimens in perioperative treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach
Participants will:
* Preoperative treatment with RC48, SOX and sindillizumab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with RC48, Tegafur,Gimeracil and Oteracil Porassium Capsules and sindillizumab for 4 cycles
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy;
HER2 expression (Immunohistochemistry: 1+,2+,3+);
Patients with clinical stage II-III;
Those who are expected to complete R0 excision;
Disqualifiers
Combined with other malignant tumors (excluding thyroid papillary carcinoma, facial basal cell carcinoma and other low-grade malignant tumors); -Patients with obstruction, bleeding, etc. who need surgical intervention after evaluation by clinicians;
dMMR/MSIH status;
Received other anti-tumor therapy before enrollment.
Trial design
Single group
Treatments tested in this trial
Perioperative treatment
DrugRC48+SOX+Sindilizumab
Treatment groups
Trial outcomes
Primary outcomes
pathological complete response rate
The proportion of subjects with node-negative lymph nodes and without residual viable tumor cells in the total number of subjects
Secondary outcomes
major pathological response rate
The proportion of subjects with surviving tumor cells ≤10% in total subjects;
Objective response rate
Proportion of patients who achieved pre-defined tumor volume reduction , including patients with complete response (CR) and partial response (PR).
Event-free survival
From the start of treatment to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause
Disease free survival
It usually starts from the time when the patient receives treatment (such as surgery), and ends at the time when the disease recurs (such as tumor recurrence, metastasis) or when the patient dies for any reason
Sponsors and contacts
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