Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer

Launched by FUJIAN MEDICAL UNIVERSITY · Jan 29, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a specific type of surgery, called palliative surgery, in patients with metastatic gastric cancer, which means the cancer has spread beyond the stomach. The researchers want to see if this surgery, performed after a treatment called translational therapy, can help patients live longer and improve their quality of life compared to those receiving ongoing chemotherapy without surgery. They will track participants for two years to see how well they do and monitor any side effects from the treatments.

To participate in this study, individuals must be between 18 and 75 years old and have a confirmed diagnosis of gastric adenocarcinoma, which is a type of stomach cancer. They should have evidence that the cancer has spread and be in relatively good health to qualify. Participants can expect regular check-ups and assessments throughout the trial to ensure their safety and gather information about their health and treatment outcomes. The trial is not yet recruiting, but it's important for potential participants to know that they will need to be committed to following the study guidelines and attending appointments.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age from 18 to 75 years
• • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically
• • CT/MRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of distant metastasis
• • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
• • Estimated survival time was over 3 months
• * The major organs are functioning normally and meet the following criteria:
• (1) Blood routine examination should meet the requirements (no blood transfusion within 14 days):
• • 1. HB≥100g/L，
• • 2. WBC≥3×109/L
• • 3. ANC≥1.5×109/L，
• • 4. PLT≥100×109/L； （2）Biochemical tests must meet the following criteria：
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• • 1. BIL \<1.5×upper limit of normal (ULN)，
• • 2. ALT and AST\<2.5ULN，GPT≤1.5×ULN；
• • 3. Cr≤1ULN，Ccr \>60ml/min
• • Fertile women must have taken a pregnancy test (serum) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last trial drug; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug
• • Did not participate in other clinical studies before and during treatment
• • Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up
• Exclusion Criteria:
• • History of other malignant disease within past five years
• • History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation
• • Accompanied by serious heart, lung, liver and kidney diseases, neuropsychiatric disorders, jaundice or associated severe infection
• • Women during pregnancy or breast-feeding
• * Subjects had poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:
• • 1. NYHA class II or more serious heart failure
• • 2. unstable angina pectoris
• • 3. myocardial infarction within 1 year
• • 4. clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention