Gastric cancer with liver metastasis
Conditions
Interventions
Experimental group:Tislelizumab combined with bevacizumab and SOX chemotherapy
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent, good compliance, and understand and follow the requirements of the study; 2. Age 18~75 years old; 3. Histologically and/or cytologically confirmed gastric or GEJ adenocarcinoma; 4. Presence of clear and measurable (in line with RECIST 1.1 criteria) liver metastases on imaging evaluation; 5. Except for liver metastasis, there are no other clinical signs of distant metastasis; 6. Laparoscopic exploration to exclude peritoneal metastasis (P0/CY0); 7. Have not received prior systemic therapy for advanced metastatic gastric cancer; 8. Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) of 0 or 1; 9. No gastrointestinal obstruction, perforation and bleeding; 10. Good organ function prior to =1.5×10^9/L; Platelet >=100×10^9/L; hemoglobin > = 90 g/L; b. Serum creatinine =30g/L; 11. Inactive/asymptomatic carriers, patients with chronic or active HBV infection need to meet the following criteria: HBV DNA < 500 IU/mL (or 2500 copies/mL) during the screening period. Patients with HCV infection who have been cured during the screening period can be enrolled; 12. Pregnant female subjects must have a serum pregnancy test within 72 hours prior to the first dose with a negative result, and be willing to use a highly effective method of contraception during the trial and for 120 days after the last dose. For male subjects whose partner is a woman of childbearing age, they should be surgically sterile or agree to use a highly effective method of contraception for the duration of the trial and for 120 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with HER2-positive gastric or GEJ adenocarcinoma; 2. R1 or R2 excision; 3. Emergency surgery due to tumor bleeding, perforation and other complications; 4. Those who have had other malignancies in the past or at the same time, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ that has achieved complete remission at least 5 years prior to screening and does not require or is not expected to require other treatment during the study period; 5. Have any of the following cardiovascular risk factors: a. Presence of cardiogenic chest pain grade 2 450 msec (males) or > 470 msec (females) with a primary ECG, a follow-up ECG will be performed to verify the results; Left ventricular ejection fraction (LVEF) of the heart = lower limit of normal (LLN) as assessed by multiple gated acquisition (MUGA) scan or echocardiography (ECHO). Follow-up assessments must be performed using the same modality used for baseline assessments; i. Any syncope or seizures occurring =grade 2); 9. Have had >=2 grade (CTCAE) gastrointestinal perforation and/or fistula (including prior gastric fistula surgery) within 6 months prior to enrollment; 10. Clinically significant intestinal obstruction (CTCAE>=grade 2); 11. Known history of human immunodeficiency virus (HIV) infection; 12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA > 500IU/mL) or active HCV carriers with detectable HCV RNA; Patients with inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA 10mg/day) or other immuno
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression Free Survival;Overall Survival;R0 resection rate; | — |
Countries
China
Contacts
Public ContactChao Yan
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed