gastric cancer
Conditions
Interventions
Experimental group:FLOT regimen combined with tislelizumab
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent (ICF); 2. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (Siewert type I-III) was performed by enhanced CT/MRI for clinical staging of cTanyNanyM+ (liver metastasis, peritoneal metastasis, or distant abdominal lymph node metastasis); 3. Clinical stage at treatment: cTanyNanyM+ (AJCC 8th Edition), liver metastasis, peritoneal metastasis and distant abdominal lymph node metastasis: (1) Enhanced CT/MRI must be performed to assess liver metastasis. Hepatobiliary surgeons evaluated liver metastases as resectable (C-GCLM classification ? /?) (see C-GCLM classification for gastric cancer liver metastases); (2) Laparoscopic exploration must be performed, and PCI score =6 months; 8. Laboratory test values within 7 days prior to enrollment must meet the following standards: (1) WBC > 4.0x10^9/L and 1.5x10^9/L, Hb >= 75g/L, PLT >= 100x10^9/L; (2) Serum bilirubin 60ml/min; (4) INR and aPTT <= 1.5 x ULN, only for subjects who did not receive anticoagulant therapy; Subjects receiving anticoagulant therapy should receive a steady dose; 9. Good compliance, can cooperate with the laboratory of this program, auxiliary inspection and corresponding specimen collection; 10. Fertile women (including those who have undergone menopause due to chemical or other medical reasons) must consent to the use of contraception for a period of at least six months, whichever is later, from the signing of the informed consent until the last administration of the study treatment or accompanying chemotherapy. Women must also agree not to breastfeed for at least six months (mostly later) from the time they sign the informed consent to the last dose of the study drug or accompanying chemotherapy; Men must consent to use birth control for at least 6 months (mostly later) from the time of administration of the investigational drug to the time of administration of the investigational drug or accompanying chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Other active malignancies within 5 years or at the same time. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., could be included in the group; 2. Patients who are preparing for or have previously received organ or bone marrow transplantation; 3. Myocardial infarction and poorly controlled arrhythmias (including QTc interval >=450ms for men and 470 ms for women) occurred within 6 months prior to initial medication (QTc interval calculated by Fridericia formula); 4. The presence of NYHA standard grade ? to ? cardiac insufficiency or color Doppler ultrasonography: LVEF (left ventricular ejection fraction) 10 mg/ day efficacy dose of prednisone) or other immunosuppressive agents within 14 days prior to initial medication or during the study period. In the absence of active autoimmune disease, patients were allowed to receive topical or inhaled steroids, or adrenal hormone replacement therapy at a dose <= 10mg/ day of prednisone efficacy; 12. Any active infection that requires systematic anti-infective therapy occurs within 14 days prior to initial medication; With the exception of prophylactic antibiotic therapy (e.g. for urinary tract infections or chronic obstructive pulmonary disease); 13. Previously received other antibody/drug therapies targeting immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.; 14. Receiving treatment in other clinical studies or planning to start treatment in this study less than 14 days before the end of treatment in the previous clinical study; 15. A known history of severe allergy to any monoclonal antibody or investigational drug excipients; 16. A known history of psychotropic substance abuse or drug use; Patients who had stopped drinking alcohol could be enrolled; 17. Patients with conditions that may increase the risk of study participation and study medication, or with other severe, acute or chronic conditions that the investigator has judged unsuitable for clinical study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease-free survival;Pathological complete response rate of primary lesion;Pathological complete/moderate tumor regression rate;Safety; | — |
Countries
China
Contacts
Public ContactLian Lei
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed