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

Fujian Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Chemotherapy; Surgery; Metastatic Gastric Cancer

Treatments: Combination Product: Palliative surgery after translational therapy; Drug: Chemotheraoy along

Study type: Interventional

Funder types: Other

Identifiers

NCT05230771

FUGES-24

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Palliative surgery after translational therapy

Experimental group

Description:

After randomization, patients received palliative surgery after translational therapy

Treatment:

Combination Product: Palliative surgery after translational therapy

Chemotherapy alone

Active Comparator group

Description:

After randomization, patients received chemotherapy alone

Treatment:

Drug: Chemotheraoy along