Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

Launched by SUN YAT-SEN UNIVERSITY · Jun 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a combination of immunotherapy and chemotherapy for treating a rare type of stomach cancer known as Borrmann type 4 or large type 3 gastric cancer. Participants in the trial will receive a medication called Tislelizumab, which helps the immune system fight cancer, along with standard chemotherapy drugs, in cycles that last three weeks. After completing six cycles, participants will undergo surgery to remove the tumor.

To be eligible for this trial, participants must be between 18 and 70 years old and have a confirmed diagnosis of gastric adenocarcinoma (a type of stomach cancer) that meets specific criteria. They should not have widespread cancer in the abdomen and need to have good overall health, meaning their organs are functioning well. Throughout the trial, participants will be closely monitored for their health and any side effects from the treatments. This trial is currently recruiting, so it’s a great opportunity for those who qualify to potentially benefit from new treatment options for their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
• • Males or females, aged 18-70 years;
• • Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
• • No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
• • ECOG performance status 0 or 1;
• * Sufficient organ function:
• • white blood cell count \> 4\*10\^9/L, neutrophil cell count \> 1.5\*10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100\*10\^9 /L
• • Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
• • Creatinine ≤ 1.5 ×ULN or serum clearance \> 60 ml/min
• • INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
• • No prior anti-tumor therapy;
• • Have signed informed consent before the beginning of treatment.
• Exclusion Criteria:
• • History of another malignancy within the last five years;
• • Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
• • Unable to take drugs orally
• • Allergic to to any drug of the study regimen;
• • Women who are pregnant or breastfeeding or may be pregnant