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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Chemotheraoy along

    Drug

    Patients receive only the prescribed chemotherapy.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Palliative surgery after translational therapyExperimental treatment 1 intervention
Group B: Chemotherapy aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

2-year overall survival rate

Survival rate of patients in the group from the date of enrollment to 2 years after enrollment

Time frame
2 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: