Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perioperative treatment.
- Who it may be relevant to
- Registry conditions: Hepatoid Adenocarcinoma of Stomach. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
Overview
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
Interventions
- Drug Perioperative treatment
RC48+SOX+Sindilizumab
Primary outcome measures
- pathological complete response rate [Time frame: within 10 days after surgery]
Secondary outcome measures (5)
- major pathological response rate [Time frame: within 10 days after surgery]
- Objective response rate [Time frame: From enrollment to surgery, assessed up to 3 months]
- Event-free survival [Time frame: From date of enrollment until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 3 years]
- Disease free survival [Time frame: From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 3 years]
- overall survival [Time frame: From date of diagnosis until the date of death from any cause, assessed up to 3 years]
Eligibility criteria
Inclusion criteria
- 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;
- ECOG score 0\~1;
- Generally in good condition, perioperative treatment and surgical resection can be tolerated;
- Patients were enrolled voluntarily.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Cancer Hospital & Institute — Beijing
Identifiers
NCT: NCT06992362 · LGH2024296