Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Mar 17, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two chemotherapy drugs, Lobaplatin and Paclitaxel, to see which one works better for patients with advanced gastric cancer who have undergone a specific type of surgery called D2 resection. The trial also includes a treatment method known as hyperthermic intraperitoneal chemotherapy, where heated chemotherapy is delivered directly into the abdominal cavity. The goal is to find out which drug helps patients survive longer and manage their cancer more effectively.

To participate in this trial, patients need to be between 18 and 75 years old and have a confirmed diagnosis of gastric adenocarcinoma (a type of stomach cancer) at an advanced stage but without spread to other parts of the body. They should not have had any previous chemotherapy or radiation treatment. Participants can expect regular check-ups and monitoring throughout the study to assess their health and response to treatment. This trial is currently recruiting participants, and it’s important for potential candidates to meet the eligibility criteria to ensure their safety and the success of the study.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
• • 2. Aged 18-75 years;
• • 3. Male or non-pregnant or lactating women;
• • 4. Pathological diagnosis of gastric adenocarcinoma;
• • 5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018);
• • 6. Normal function of major organs;
• 7. Routine blood examinations meeting the following criteria:
• • A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L;
• 8. Chemistry indexs meeting the following criteria:
• • A. TBIL \< 1.5ULN; B. ALT and AST \< 2.5ULN; ALB \> 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
• • 9. ECOG score 0-1;
• Exclusion Criteria:
• • 1. A history of other malignant tumors within 5 years;
• • 2. Distant metastasis found during surgery;
• • 3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
• • 4. Suffering from epilepsy or other mental illness, unable to control behavior;
• • 5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
• • 6. Pregnant or lactating women.
• • 7. Receiving anti-cancer drug therapy from other clinical trials.