PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer

Launched by WAN HE · Aug 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced gastric cancer, which is a type of stomach cancer. The researchers want to see if combining a drug called toripalimab, which helps the immune system fight cancer, with a specific chemotherapy regimen (called FLOAP) can improve outcomes for patients. They are particularly interested in whether this combination leads to a complete response to treatment, meaning no cancer is detected after therapy, and if it can help patients live longer without the disease returning.

To participate in this trial, patients need to be between 18 and 79 years old and have a confirmed diagnosis of gastric or gastroesophageal junction cancer. They should have not received certain prior treatments and need to meet specific health criteria, such as having adequate blood counts and organ function. Participants will receive the treatment and undergo regular monitoring to assess the effectiveness and any potential side effects. This trial is currently recruiting participants, and it aims to offer new hope for better management of gastric cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 yeas and ≤79 years. The gender is not limited.
• • 2. Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.
• • 3. Endoscopic ultrasonography and/or enhanced CT/MRI examination confirmed at the stage of cT3/4a Nx or T2 N1-3, M0(AJCC 8th) before randomization.
• • 4. At least 15 unstained sections of formalin-fixed paraffin-embedded tumor tissue sections or fresh tumor tissues can be provided for PD-L1, TMB, tumor infiltrating T lymphocytes, MSI-H/dMMR and EBV detection.
• • 5. The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1
• 6. Adequate bone marrow and organ function meets the following criteria:
• • 1. Neutrophil count (ANC)≥1.5×l09/L
• • 2. Platelet (PLT) ≥80×109/L
• • 3. Hemoglobin (Hb) level ≥9.0 g/L
• • 4. Total bilirubin level≤1.5×ULN
• • 5. Alanine aminotransferase (ALT) level≤3×ULN
• • 6. Aspartate aminotransferase (AST) level ≤3×ULN
• • 7. International normalized value (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN
• • 8. Serum creatinine (Cr) level ≤1.5×ULN
• • 9. Creatinine clearance \>50 ml/min (Calculated according to the Cockcroft-Gault formula)
• Exclusion Criteria:
• • 1. Patients with a history of severe hypersensitivity to other monoclonal antibodies or any component of toripalimab injection (JS001).
• • 2. Preoperative pathology diagnosed as squamous cell carcinoma or neuroendocrine tumor.
• • 3. Patients have experienced or currently have other malignancies within 5 years.
• • 4. Patients have received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA4 agent.
• • 5. Patients with history of autoimmune disease; patients with autoimmune-related hypothyroidism receive stable doses of thyroid hormone replacement therapy Eligible to participate in this study; Type 1 diabetes patients who are controlled after receiving a stable insulin treatment plan are eligible to participate in this study;
• • 6. Patients have received systemic immunostimulatory drug therapy (including but not limited to interferon or IL-2) within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is shorter);
• • 7. Patients who have undergone allogeneic bone marrow transplantation or solid organ transplantation in the past;
• • 8. Active infections, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical routines), hepatitis B {known HBV surface antigen (HBsAg) positive, and HBV DNA ≥1000cps/ml}, hepatitis C or human immunodeficiency virus (HIV antibody positive).
• • 9. Patients with previous or cured HBV infection (defined as hepatitis B core antibody \[anti-HBc\] positive and HbsAg negative) are only eligible to participate in this study when HBV DNA is negative (HBV DNA ˂1000cps/ml).
• • 10. Patients with positive hepatitis C (HCV) antibodies are only eligible to participate in this study if the polymerase chain reaction shows negative HCV RNA.
• • 11. There is a serious neurological or mental illness, including dementia and seizures.
• • 12. Suffer from NCI-CTCAE ≥ Grade 2 peripheral neuropathy.
• • 13. Women who are pregnant or breastfeeding.
• • 14. Chronic bowel disease or short bowel syndrome.
• • 15. Those who are deficient in the enzyme dihydropyrimidine dehydrogenase (DPD).
• • 16. Major cardiovascular diseases, such as New York Heart Association heart disease (level II or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia, or unstable angina.
• • 17. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction \<50% must adopt an optimized and stable medical plan determined by the treating doctor. If necessary, you can consult a cardiologist.