Gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Systemic Chemotherapy Group:Systemic Chemotherapy
Systemic Chemotherapy Combined with Highly Selective Transarterial Chemoembolization Group:Systemic Chemotherapy Combined with Highly Selective Transarterial Chemoembolization
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand the study and voluntarily sign the informed consent form (ICF); 2.Histologically confirmed gastric or gastroesophageal junction adenocarcinoma; 3.Deemed unresectable after multidisciplinary team (MDT) discussion; 4.No gender restriction; age 18–75 years; 5.Good general condition: ECOG performance status 0–1, with no surgical contraindications; 6.Adequate physical condition and organ function to tolerate major abdominal surgery; 7.Expected survival >= 3 months; 8. Laboratory test values within 7 days prior to enrollment must meet the following criteria: a. Hemoglobin > 80g/L; b. WBC > 4.0×10^9/L and 1.5×10^9/L, Hb > = 80g/L, PLT > = 100×10^9/L; c. Serum bilirubin 60 ml/min, estimated by Cockcroft-Gault glomerular filtration rate: (140 - age) × (weight, kg) × (0.85 if female)/72 × (serum creatinine, mg/dL) Or: (140 - age) × (weight, kg) × (0.85 if female) / 0.818 × (serum creatinine, µmol/L) e. INR and aPTT <= 1.5 × ULN for subjects who are not on anticoagulant therapy only; Subjects receiving anticoagulation should be on a stable dose 9. Good compliance, can cooperate with the laboratory, auxiliary examination and corresponding specimen collection of this protocol; 10. Women of childbearing potential (including those who have menopause due to chemical menopause or other medical reasons) must agree to use contraception for at least 5 months after the last dose of study treatment or concomitant chemotherapy, whichever is later, from the time of signing the informed consent. Females must also agree not to breastfeed for at least 5 months (whichever is later) from receiving chemoradiotherapy or interventional therapy; Males must agree to use contraception for at least 7 months (whichever is later) from receiving chemoradiotherapy or interventional therapy.
Exclusion criteria
Exclusion criteria: 1.Gastrointestinal perforation or significant risk of perforation; 2.Evidence of distant metastasis; 3.Contraindications to contrast agent administration; 4.Inability to meet conditions for interventional puncture (e.g., vascular access limitations); 5.HER2-positive (+++) by immunohistochemistry (IHC); 6.Mismatch repair (MMR) protein proficiency by IHC and microsatellite instability-high (MSI-H) confirmed by genetic testing; 7.Concurrent or history of other malignancies (excluding fully resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any cancer with no recurrence for =5 years); 8. Uncontrollable pericardial effusion, pleural effusion or ascites, gastrointestinal bleeding or high risk of bleeding within 2 weeks of enrollment; 9. Weight loss of more than 20% within 2 weeks of enrollment; 10. Have received any anti-infective vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment; 11. Uncontrolled diabetes, hypertension and other systemic diseases; 12. Is receiving or requiring anticoagulant therapy (except for antiplatelet therapy, including low-dose aspirin); 13. Subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or who have had complete remission of asthma in childhood and do not require any intervention after adulthood may be included; Asthma requiring medical intervention with bronchodilators could not be included); 14. Subjects with active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis therapy or have received anti-tuberculosis therapy within 1 year prior to screening; 15. History of the following pulmonary diseases confirmed by imaging (preferably CT) or clinical results: interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, acute lung disease; 16. Pregnant or lactating women or may become pregnant; 17. Severe coagulation dysfunction; 18. Positive results of any of the following tests: human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody, human T-lymphotropic virus-1 (HTLV-1) antibody, hepatitis C virus (HCV) antibody; Any other clinically significant disease or condition that, in the opinion of the investigator, could affect protocol compliance, or affect the subject's signing of the informed consent form (ICF), or would not be suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 Resection Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response;1 year Progression-Free-Survival;5 years Overall Survival;3 years Progression-Free-Survival;Safety;Perioperative complication rate;Tolerance;Quality of life; | — |
Countries
China
Contacts
Public ContactShoujiang Wei
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed