Gastric cancer
Conditions
Interventions
Experimental group:Disitamab Vedotin:2.5mg/kg,D1,iv,Q3W
Trastuzumab: 200mg, D1, iv, Q3W
Tegio: 40-60mg/time, oral, bid,D1-14, Stop taking medication for 7 days
Every 3 weeks is a treatment cycle.
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 and above, gender not limited; 2. Late stage inoperable gastric or gastroesophageal junction adenocarcinoma diagnosed by pathology; 3. HER-2 immunohistochemistry detected 1+or 2+FISH negative; 4. At least one measurable lesion that meets the RECIST v1.1 criteria; 5. No previous systemic treatment, or having received neoadjuvant/adjuvant chemotherapy, but experiencing disease progression or recurrence 6 months after the end of treatment; 6. ECOG PS: 0-1 point; 7. Adequate organ function: Bone marrow function: hemoglobin >= 90g/L; Absolute neutrophil count >= 1.5 × 10^9/L; white blood cell count >= 3.0 × 10^9/L; platelets >= 100 × 10^9/L; liver function: serum total bilirubin = 60 mL/min; Cardiac function: NYHA classification= 50% 8. Expected survival period >= 12 weeks; 9. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug. For males, they must agree to use appropriate contraception methods or undergo surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 10. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Any allergy to the investigational drug or its excipients, or a history of severe allergies, or contraindications to the investigational drug; Clinical symptoms or diseases of the heart that have not been well controlled, such as: a. NYHA grade 2 or above heart failure; b. Unstable angina pectoris; c. Have experienced myocardial infarction within one year; d. Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; 2. Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti gastric cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use for ascites control); 3. Serious cardiovascular and cerebrovascular events have occurred within the past 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (excluding asymptomatic and untreated lacunar cerebral infarction); 4. Have a history of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.); 5. History of immunodeficiency or autoimmune diseases, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or autoimmune diseases; 6. There is brain metastasis or leptomeningeal metastasis; 7. Having undergone any major surgical procedures = 28 days prior to the first study drug administration; 8. At present, there are digestive tract diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation; Or those who have a history of intestinal perforation or fistula and have not recovered after surgical treatment 9. Previously undergone allogeneic stem cell transplantation or organ transplantation; 10. According to the researcher's judgment, there are accompanying diseases that pose a serious threat to the safety of the subjects or affect their ability to complete clinical research; 11. According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, serious laboratory test abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples; 12. Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 13. Other researchers evaluated those who did not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival;Duration of Response;Disease Control Rate;Adverse Event;Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactAina Liu
Yantai Yuhuangding Hospital
Outcome results
None listed