NCT05230771Not yet recruitingPhase 3
Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer
Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 5 Dec 2021
- Start date
- 1 Apr 2022
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Fujian Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05230771
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 1 Apr 2022 to the primary completion date, 1 Mar 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Subjects had poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:
- NYHA class II or more serious heart failure
- unstable angina pectoris
- myocardial infarction within 1 year
- clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention
Other
- Women during pregnancy or breast-feeding
Who the study is looking for
- 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):
- HB≥100g/L,
- WBC≥3×109/L
- ANC≥1.5×109/L,
- PLT≥100×109/L; (2)Biochemical tests must meet the following criteria:
- <!-- -->
- BIL \<1.5×upper limit of normal (ULN),
- ALT and AST\<2.5ULN,GPT≤1.5×ULN;
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.