Ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Neoadjuvant Transformation Therapy for Advanced Gastric Cancer

Launched by YANG JIANJUN, PHD · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for advanced gastric cancer, which is a type of stomach cancer that has spread. The researchers want to see how effective and safe a combination of four medications—ramucirumab, nab-paclitaxel, lobaplatin, and S-1—are when given before surgery. The goal is to find out if this treatment can help shrink the cancer enough so that it can be completely removed during surgery, and to assess any side effects that may occur.

To participate in this trial, patients must be between 18 and 75 years old and have been diagnosed with advanced gastric cancer that requires treatment before surgery. They should not have had any prior cancer treatments and must meet certain health criteria to ensure their bodies can handle the medication. Participants will be monitored closely throughout the trial to track how well the treatments work and any side effects they may experience. This study is being conducted at a single hospital, and ethical approval has been granted to ensure the safety and rights of all participants.

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Eligibility criteria

• Inclusion Criteria:
• • Cohort A: Patients are diagnosed with locally advanced gastric or gastroesophageal junction adenocarcinoma by cytology or histopathology and in need of preoperative neoadjuvant therapy to reduce recurrence and metastasis rates; Cohort B: Patients with advanced gastric cancer who have undergone surgery after neoadjuvant chemotherapy with previously used nab-paclitaxel, lobaplatin and S-1.
• • Patients are adults aged 18-75 years with an Eastern Cooperative Oncology Group(ECOG) performance status score less than or equals to 1.
• • Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy) .
• • Functions of the major organs and bone marrow meet the following criteria within 7 days before treatment: hemoglobin ≥ 80g/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet (PLT) ≥ 100× 109/L, without blood transfusion within 14 days, total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5x ULN or if complicated with liver metastasis then ALT and AST ≤ 5x ULN, serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 50mL/min or urinary protein\<2+, activated partial thromboplastin time (APTT) and international standardized ratio (INR)≤1.5×ULN.
• • Expected lifespan ≥ 6 months. The patients are able and willing to provide written informed consent to participate in the study.
• Exclusion Criteria:
• • Patients who have previously suffered from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
• • HER-2 positive patients who are willing to receive Herceptin treatment. Women who are pregnant or lactating or in the reproductive period and have not taken effective contraceptive measures, or those who have fertility requirements during the research period.
• • Patients with serious and uncontrolled internal diseases and infections or with chronic bowel disease or short bowel syndrome.
• • Patients with major organ failure, such as compensatory heart, lung, liver, and kidney failure as well as severe metabolic abnormalities in liver and kidney which affects normal drug metabolism.
• • Patients with a clear tendency for gastrointestinal bleeding and/or abnormal coagulation function (INR\>1.5)under researchers evaluation.
• • hepatitis B virus or hepatitis C virus in active phase Patients with peripheral neuropathy neoadjuvant chemotherapy(NCT)-CTCAE ≥ Level 2.
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