Metastatic Gastric CancerPhase 3NCT05230771
Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer
A Phase 3 study testing Palliative surgery after translational therapy and Chemotheraoy along in people with Metastatic Gastric Cancer and Surgery, run by Fujian Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Gastric Cancer, Surgery, Chemotherapy
- What is being tested?
- Palliative surgery after translational therapy and Chemotheraoy along
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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：
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- 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
Who cannot join
- 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:
- NYHA class II or more serious heart failure
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- unstable angina pectoris
- myocardial infarction within 1 year
- clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention
About this study
Official title: Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled 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.
- Conditions
- Metastatic Gastric Cancer, Surgery, Chemotherapy
- Being tested
- Palliative surgery after translational therapy, Chemotheraoy along
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative surgery after translational therapyCombination product
A total, distal, or proximal gastrectomy with D1 lymph node dissection was done depending on tumour after translational therapy .
location.
Chemotheraoy alongDrug
Patients receive only the prescribed chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Palliative surgery after translational therapy | Experimental | After randomization, patients received palliative surgery after translational therapy Receives: Combination Product: Palliative surgery after translational therapy |
| Chemotherapy alone | Active comparator | After randomization, patients received chemotherapy alone Receives: Drug: Chemotheraoy along |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival rate
Survival rate of patients in the group from the date of enrollment to 2 years after enrollment
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230771
- Sponsor's protocol ID
- FUGES-24
- Status last verified
- Mar 2022
- First submitted
- 5 Dec 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05230771
- Acronym / sponsor ID
- FUGES-24
- Conditions
- Metastatic Gastric Cancer, Surgery, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative surgery after translational therapy | Experimental | Combination Product: Palliative surgery after translational therapyAfter randomization, patients received palliative surgery after translational therapy |
| Chemotherapy alone | Active comparator | Drug: Chemotheraoy alongAfter randomization, patients received chemotherapy alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative surgery after translational therapyA total, distal, or proximal gastrectomy with D1 lymph node dissection was done depending on tumour after translational therapy . location. | Combination product | Palliative surgery after translational therapy |
| Chemotheraoy alongPatients receive only the prescribed chemotherapy. | Drug | Chemotherapy alone |
Primary outcome
2-year overall survival rate
Time frame: 2 year
Survival rate of patients in the group from the date of enrollment to 2 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palliative surgery after translational therapy and Chemotheraoy along in people with Metastatic Gastric Cancer and Surgery, run by Fujian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival rate (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.