Hepatoid adenocarcinoma of stomach
Conditions
Interventions
Experimental group:1. Neoadjuvant therapy: albumin paclitaxel 150mg/kg, intravenous infusion, d1, every 21 days
sintilimab 200mg, intravenous infusion, d1, every 21 days
Tigio (administered by body surface area: BSA=1.25m2,=1.5m^2, 60mg), orally, twice a day, d1-14, every 21 days
oxaliplatin 85mg/m2, intravenous infusion, d1, every 21 days. There are 4 cycles of neoadjuvant therapy.
2. Radical surgery within 4-6 weeks after the end of neoadjuvant therapy.
3. Adjuvant therapy:
Tigio (administered by body surface area: BSA=1.25m^2,=1.5m^2, 60mg), orally, twice a day, d1-14, every 21 days. There are 4 cycles of adjuvant therapy.
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participated in this study, are able to sign the informed consent form and have good compliance. 2.Age: 18 - 75 years old (at the time of signing the informed consent form), gender not limited. 3.Patients with histologically confirmed hepatoid adenocarcinoma of the stomach, with imaging findings indicating locally advanced disease (clinically staged as II-III according to the 8th edition of AJCC), and who consent to receive radical surgical treatment, and whose lesions are deemed resectable by the investigators; those who have not received systemic treatment for the current disease, including anti-tumor radiotherapy and chemotherapy/immunotherapy, etc. in the past. 4.The immunohistochemical result of HER2 detection was 0. 5.ECOG score ranging from 0 to 1 point. 6.Expected survival period = 6 months. 7.The main organs function well and can tolerate chemotherapy, immunotherapy and surgery. 8.During the study period and within 3 months after the study concludes, fertile subjects must adopt medically approved and effective contraceptive measures (including physical contraception, surgical contraception, abstinence, etc.), have negative serum pregnancy test results within 7 days before being enrolled in the study, and must be non-lactating subjects.
Exclusion criteria
Exclusion criteria: 1: Within five years prior to the first administration, other malignant diseases were diagnosed except for gastric cancer (excluding skin basal cell carcinoma and/or squamous cell carcinoma that have undergone radical cure, and/or carcinoma in situ that has undergone radical resection); 2: The tumor lesion has a tendency to bleed (such as when there is an active ulcerative tumor lesion and the fecal occult blood test is positive, when there is a history of hematemesis or melena within 2 months before signing the informed consent form, or when the researcher judges that there is a risk of major gastrointestinal bleeding, etc.); 3: Patients with dMMR/MSIH gastric cancer; 4: Unable to take oral medication; 5: Currently participating in an interventional clinical trial for treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration of the current drug; 6: Within 2 weeks prior to the first administration, received systemic and systemic treatment with traditional Chinese medicine or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally for controlling pleural effusion) with anti-tumor indications; 7: Within two years prior to the first administration, there has been a history of active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants). Therapies that are alternative to systemic treatment (such as thyroid hormone, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not regarded as systemic treatment; 8: The study excluded subjects who were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoid routes) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: Physiological doses of glucocorticoids (= 2; 12: It is known that the history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 13: Subjects with active hepatitis B or hepatitis C (HBsAg positive and HBV DNA detected with a titer higher than the upper limit of normal value; HCVAb positive and HCV RNA detected with a titer higher than the upper limit of normal value); 14: Before the first administration (during the 1st cycle, on the 1st day), received live vaccines within 30 days prior to the first administration; (Note: Live attenuated influenza vaccines for seasonal influenza can be administered within 30 days before the first administration; however, inactivated virus vaccines for seasonal influenza injection are not allowed. Reduced-dose live influenza vaccines administered by nasal route are not permitted.); 15: Pregnant or lactating women; 16: There are any serious or uncontrollable systemic diseases, such as a) significa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completely pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Objective response rate;Exploration of therapeutic efficacy-related biomarkers and mechanisms of drug resistance;Disease-free survival period;Major pathological remission rate;Overall survival; | — |
Countries
China
Contacts
Public ContactAnqiang Wang
Beijing Cancer Hospital/Peking University Cancer Hospital
Outcome results
None listed