Malignant ascites of Gastric cancer
Conditions
Interventions
Group A:PD-1 antibody intratumoral injection combined with apatinib
Sponsors
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with advanced gastric cancer proven histologically or cytologically; 3. Patients with malignant ascites need ascites puncture treatment; 4. Standard treatment fails, or there is no standard treatment option, or the patient rejects standard treatment; 5. The time interval between the most recent antitumor treatment and the first administration of the drug shall meet the following time interval: if the patient's most recent antitumor treatment is determined to be PD according to RECIST 1.1 criteria, it shall be >=2 weeks from the first administration of the experimental drug; Patients with non-PD from their most recent antitumor therapy according to RECIST 1.1 criteria must be >=4 weeks from the first administration of the investigational drug or 5 half-lives from their most recent antitumor therapy; 6. Has recovered from any toxic reactions to the previous drug (grade 0-1 according to NCI-CTCAE v 4.03); 7. ECOG score 0-2; 8. Expected survival time greater than 8 weeks; 9. Normal levels of organ function; 10. Can swallow pills normally.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergies to carrizumab or apatinib; Or a history of specific allergic reactions (asthma, rubella, eczematous dermatitis) or a clear history of allergy to macromolecular antibodies; 2. Have used similar monoclonal antibodies or small molecule inhibitors within 4 months before the first administration; 3. Patients with high blood pressure that cannot be controlled; 4. Uncontrolled active infection (CTCAE >=2); 5. Patients with severe diarrhea (CTCAE >=2); 6. Severe dyspnea requiring oxygen therapy; 7. Active autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autohemolytic anemia, sclerotic disease, severe psoriasis, rheumatoid arthritis), but the following conditions are allowed to be screened: Type 1 diabetes mellitus, hypothyroidism that can be controlled by alternative therapy alone, skin conditions (such as vitiligo, psoriasis, or hair loss) that do not require systemic treatment; 8. Patients with squamous cell carcinoma of the stomach or gastroesophageal junction; 9. Other serious conditions that may limit patients' participation in the study (such as uncontrolled diabetes mellitus, severe gastrointestinal disease, bleeding tendency, gastrointestinal perforation or fistula, etc.); 10. Insufficient cardiac function, NYHA grade 3 or 4; 11. Complete intestinal obstruction occurred within 30 days before the first administration of the drug, or incomplete intestinal obstruction was diagnosed as unsuitable for the study based on symptoms, signs, etc.; 12. The ascites cannot be drained clean due to objective reasons; 13. A history of immunodeficiency, including HIV positive; 14. Active hepatitis B virus infection (HBV DNA quantification >=1*10000copies/mL or 2000IU/mL), hepatitis C virus antibody, syphilis antibody and HIV antibody positive; 15. Pregnant or lactating women; 16. Those who want to have children within six months; 17. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia; 18. Those who received clinical investigational active drug treatment within 1 month before the first administration; 19. Other circumstances in which the Investigator deems it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Laboratory examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| The volume of ascites;Symptoms and signs of ascites; | — |
Countries
China
Contacts
Public ContactZhang Tao
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed