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This single-center, prospective study was conducted to investigate the efficacy and safety of palliative surgery after translational therapy in the treatment of metastatic gastric cancer. The primary endpoint was 2-year overall survival (OS) rate. Secondary endpoints were median OS, progression-free survival (PFS), 1-year OS, adverse events (AE), severe AE, the quality of life (QOL) and treatment cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative surgery after translational therapy | Experimental | After randomization, patients received palliative surgery after translational therapy |
|
| Chemotherapy alone | Active Comparator | After randomization, patients received chemotherapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative surgery after translational therapy | Combination Product | A total, distal, or proximal gastrectomy with D1 lymph node dissection was done depending on tumour after translational therapy . location. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year overall survival rate | Survival rate of patients in the group from the date of enrollment to 2 years after enrollment | 2 year |
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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):
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:
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| Chemotheraoy along | Drug | Patients receive only the prescribed chemotherapy. |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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