Gastric/Gastric Fundus Adenocarcinoma
Conditions
Interventions
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The participants must meet all of the following criteria to be included in this study: 1. Histological or cytological diagnosis of unresectable oligometastatic adenocarcinoma of the stomach or gastroesophageal junction (TNM stage: IV); 2. The liver metastases have been confirmed or verified by pathological or imaging examinations, with no more than 3 metastatic lesions, each with a longest diameter of = 1.5 × 10^9/L, platelet count >= 90 × 10^9/L, hemoglobin >= 90 g/L (no blood transfusion within 14 days), serum total bilirubin = 50 ml/min; 4. Age greater than 18 years old, gender not limited; 5. ECOG performance status score of 0-1; 6. Must have at least one measurable lesion of liver metastasis, in accordance with the RECIST 1.1 evaluation criteria; 7. Pregnant women of childbearing age must have a serum ß-HCG test confirmed as not pregnant. During the entire study period and within 12 weeks after the last administration of the study product, pregnant women must use appropriate methods of contraception to reduce the risk of pregnancy; 8. Patients with bone metastasis are allowed to receive bisphosphonate treatment simultaneously; 9. Patients with jaundice must undergo biliary drainage and decompression surgery before enrollment, with total bilirubin <= 2.5 x ULN; 10. Can understand and sign the written informed consent form; expected good compliance; 11. Expected survival period of more than 3 months.
Exclusion criteria
Exclusion criteria: Inclusion criteria A subject must meet all of the following criteria to be eligible for this study: 1. Histological or cytological diagnosis of unresectable oligometastatic adenocarcinoma of the stomach or gastroesophageal junction (TNM stage: IV); 2. Liver metastases are confirmed or demonstrated by pathological or imaging examinations, with no more than 3 metastatic lesions, each with a maximum diameter of = 3 cm, and single metastatic lesion with a maximum diameter of = 5 cm, without other organ metastases; 3. Within 7 days before screening (including the 7-day period), laboratory test requirements: neutrophil count = 1.5 × 109/L, platelet count = 90 × 109/L, hemoglobin = 90 g/L (no blood transfusion within 14 days), serum total bilirubin = 1.5 times the upper limit of normal (ULN); ALT and AST = 2.5 x ULN (for patients with liver metastases = 5 x ULN); serum creatinine = 1.5 x ULN or creatinine clearance rate = 50 ml/min; 4. Age greater than 18 years, gender not limited; 5. ECOG performance status score of 0-1; 6. Must have at least one measurable lesion of liver metastasis, in accordance with RECIST 1.1 evaluation criteria; 7. Pregnant women of childbearing age must have a serum ß-HCG test confirmed as not pregnant. During the entire study period and within 12 weeks after the last administration of the study product, pregnant women must use appropriate methods of contraception to reduce the risk of pregnancy; 8. Patients with bone metastases are allowed to receive bisphosphonate treatment simultaneously; 9. Patients with jaundice must undergo biliary drainage and decompression surgery before enrollment, with total bilirubin = 2.5 x ULN; 10. Can understand and sign a written informed consent form; expected good compliance; 11. Expected survival period of more than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival ;Objective response rate;Disease control rate;The tolerance and safety of the treatment plan; | — |
Countries
China
Contacts
Public ContactXiaoyan Zhu
Fudan University Shanghai Cancer Center
Outcome results
None listed