AFP-positive gastric cancer
Conditions
Interventions
Experimental group:FLOT chemotherapy sequential carrelizumab and apatinib mesylate
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 70 years old, regardless of gender; 2. Diagnosed as gastric cancer by histology or cytology, with measurable tumor lesions (spiral CT or MR scan >= 10mm, meeting RECIST 1.1 standard); 3. Patients whose AFP level has increased by more than 10 mg/L in two consecutive serological tests; 4. Have not previously received systemic treatment for gastric cancer, including immunotherapy, chemotherapy, etc.; 5. HER2 is negative. The definition of HER2 negative is: IHC (0 or 1+) or fluorescence in situ hybridization (FISH) negative (HER2:CEP17 ratio 3 months; 8. ECOG PS score: 0-1 points; 9. The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period): 1) The absolute count of neutrophils >= 1.5 x 10^9/L; platelets >= 100 x 10^9/L; hemoglobin >= 9g/dL; 2) Thyroid-stimulating hormone (TSH) 50 ml/min. 10. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment,women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraceptive measures uninterruptedly during treatment and 6 months after the last treatment dose; 11. The subject voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding, or have fertility but refuse to take contraceptive measures; 2. History of other malignant tumors in the past 5 years; 3. Allergy to any test drug and its excipients, a history of severe allergies or contraindications to the test drug 4. People with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 5. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severely impaired lung function 6. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) can be selected 7. Patients with active hepatitis B or C, chronic infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 1000IU/mL are allowed to participate in the study, but they need to continue during the study period Or start full-course standardized antiviral treatment; 8. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery; 9. Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period; 10. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab; 11. Known history of HIV infection; 12. Active bleeding or abnormal blood coagulation (PT > 16s, APTT > 43s, INR > 1.5 x ULN), or bleeding or thrombolysis, anticoagulation or antiplatelet therapy trends with clinical symptoms of moderate or above pleura and ascites; 13. A history of gastrointestinal bleeding or bleeding tendency within 6 months before admission; 14. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which can seriously affect the use and absorption of medications); 15. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 16. The researcher thinks it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;DCR;OS;safety; | — |
Countries
China
Contacts
Public ContactYu Han
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed