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Metastatic Gastric CancerCYGAS-GCNCT06768463

Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer

A study testing Cytoreductive Gastrectomy in people with Metastatic Gastric Cancer and Gastric Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The results of the current studies to determine the optimal strategy for metastatic gastric cancer remain contrversial worldwide. Hypothesis: Cytoreductive Gastrectomy After Systemic Therapy will improve survival time for metastasis gastric cancer compared to Systemic Therapy alone. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cytoreductive Gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteVietnam
Study dates
1 Aug 2025to 10 Dec 2027
Phase
Interventional
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 18-75
  • GCLM detected on surgical exploration and demonstrated by histology or cytology
  • Localized peritoneal carcinomatosis (P1 or P2 score), according to the classification of the Japanese Research Society for Gastric Cancer
  • Liver metastasis lesions of maximum diameter ≤5 cm
  • Para-aortic lymph node metastasis below the coeliac axis or above the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter≥1cm)
  • Bilateral or unilateral Krukenberg tumors were allowed and considered 1 incurable organ site
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  • The accepted patient has two metastases
  • Baseline Eastern Cooperative Oncology Group (ECOG) performance status < 1
  • Basic laboratory tests demonstrating adequate bone marrow function (neutrophil count > 1500mm3, haemoglobin > 8g/dL, platelet count > 100,000/mm3), adequate liver function (bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within upper limits of normal), adequate renal function (serum creatinine within the upper limit of normal)
  • Expected survival > 3 months
  • Able to tolerate enteral nutrition and adequate mental capacity to give informed consent
  • Completed 4 cycles of first-line standard-of systemic therapy
  • Repeat diagnostic laparoscopy after first-line treatment prior to randomization demonstrating feasible resection.
  • Eligibility criteria for resection \& extent of proposed resection
  • Staging scans (cross-sectional imaging) demonstrating no extra metastases (lung, bone,...)
  • Cross-sectional imaging demonstrating no local progression of PM
  • PCI score <12
  • Cytology +ve alone (no gross PM) permissible for enrolment
  • Feasible R0 resection (reasonable chance of negative margins on histology)
  • Feasible D1, D1+ or D2 lymphadenectomy

Who cannot join

  • Any extra-abdominal metastasis at diagnosis or during systemic treatment.
  • Past history of malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix
  • Patients in the reproductive age who declined to use an adequate means of contraception
  • Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study
  • Uncontrolled concurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
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  • Pregnant and lactating females
  • Prior surgical treatment for GC involving resection
  • Clinical or radiological progression during 1st line systemic treatment
  • Patients with radiological progression of LM (determined by RECIST criteria) to be excluded as disease is likely not responding well to 1st line treatment.
  • Patients with clinical progression of LM as defined by increasing ascites requiring intervention (ascitic tap/drain, hospital admission etc) or causing significant symptoms to the patient (tense distended abdomen, early satiety, shortness of breath etc).
  • Ascites volume as a reflection of disease control is difficult to assess and quantify or a reflection of disease progression. (15)
  • Any patient deemed unresectable or requiring extensive resection beyond procedure approved in the study protocol
  • PCI > 12
  • Extensive bowel / mesentery involvement requiring >2 separate / non-contiguous small or large bowel resections in addition to the gastrectomy
  • Involvement of the head of pancreas or bile duct
  • PM or nodal disease in the hepatoduodenal ligament
  • Involvement of major vascular structures
  • Involvement of esophagus precluding a reasonable chance of R0 resection by transhiatal approach Withdrawal Criteria
  • Patient decides to withdraw from the study, or
  • The investigator concludes that it is in the patient's best interest to discontinue study treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vo D Long, Prof. contact

+84918133915

long.vd@umc.edu.vn

Nguyen V Hai, MD contact

hai.nv@umc.edu.vn

Vietnam1 site, 1 recruiting
  • University Medical Center

    Ho Chi Minh City, Ho Chi Minh, 700000

    Long D. Vo, PhD, MD, +84.918133915, long.vd@umc.edu.vn

    Dat Q. Tran, MsC, MD, +84.905621107, dat.tq@umc.edu.vn

    Recruiting

Other trials in Vietnam

About this study

Official title: Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer: An Open-label Randomized Controll Trial

The results of the current studies to determine the optimal strategy for metastatic gastric cancer remain contrversial worldwide.

Hypothesis: Cytoreductive Gastrectomy After Systemic Therapy will improve survival time for metastasis gastric cancer compared to Systemic Therapy alone.

Read the detailed description

Stomach cancer in Vietnam is often detected at a late stage, with about 30% of patients having distant metastases within the abdomen at the time of diagnosis. The optimal treatment choice for patients at this stage remains unclear. For cases with distant metastases within the abdomen, such as liver metastasis, peritoneal metastasis, or lymph node metastasis along the aorta (16a2/b1), systemic therapy remains the standard treatment unless there are complications such as bleeding or pyloric stenosis. Survival time for these cases is generally less than 1 year according to previous studies. However, with advances in gastric cancer treatment, many recent studies show a significant improvement in the survival of this group. According to the results of the Regatta study, the median survival time was 16.6 months for patients receiving only chemotherapy and 14.3 months for those undergoing gastrectomy followed by chemotherapy. This is the largest randomized comparative study to date comparing the efficacy of chemotherapy alone versus gastrectomy followed by chemotherapy. The study results showed that gastrectomy did not significantly improve survival for patients. Therefore, according to current treatment guidelines of the Japanese Gastric Cancer Association or the European guidelines, systemic systemic therapy remains the recommended option for cases of gastric cancer with intra-abdominal metastases.

However, according to the authors of the Regatta study, after a longer follow-up period and a more detailed analysis of the relationship between overall survival and the characteristics of gastric cancer, it was found that for lower third gastric cancer, gastrectomy had better survival outcomes compared to chemotherapy alone. For middle third gastric cancer, survival outcomes were equivalent between the two groups, while for upper third gastric cancer, total gastrectomy had worse survival outcomes compared to chemotherapy alone. This difference is explained by the fact that after total gastrectomy, the patient's general condition deteriorates, making it impossible to tolerate postoperative chemotherapy. Therefore, for advanced-stage gastric cancer, many studies recommend preoperative systemic therapy to increase drug tolerance, increase the rate of R0 resection, and improve survival. The JCOG 0605 study for bulky lymph node or para-aortic lymph node metastatic gastric cancer showed that preoperative chemotherapy helped achieve an R0 resection rate of 82%, with 3-year and 5-year survival rates of 59% and 53%, respectively, which were better than expected. Additionally, many other studies on the treatment of metastatic gastric cancer have also shown the effectiveness of neoadjuvant systemic therapy combined with gastrectomy and postoperative systemic therapy. The CONVO-GC-1 multicenter retrospective study in Japan, South Korea, and China with 1206 cases of metastatic gastric cancer who underwent gastrectomy after neoadjuvant systemic therapy showed an overall median survival of 36.7 months, with median survival for R0, R1, and R2 resection groups being 56.6 months, 25.8 months, and 21.7 months, respectively. This result shows that preoperative systemic therapy combined with gastrectomy and postoperative systemic therapy has the potential to improve survival for advanced-stage gastric cancer patients.

Additionally, studies on targeted therapy have also shown effectiveness in the treatment of advanced gastric cancer, improving patient survival. The randomized multicenter ToGA study conducted in 24 major hospitals worldwide showed that Trastuzumab combined with systemic therapy was effective in improving survival for metastatic gastric cancer compared to systemic therapy alone, with median survival times of 13.8 months versus 11.1 months (HR = 0.74; 95% CI: 0.60-0.91; p = 0.0046). Other studies on this topic have shown similar results, so currently, Trastuzumab combined with systemic therapy is recommended as the first choice for metastatic gastric cancer expressing Her 2.

The results of the above studies form the basis for current research trends at many major centers worldwide to determine the optimal strategy for metastatic gastric cancer, which remains an open question. Whether to choose systemic therapy as per current treatment guidelines or to combine systemic therapy with gastrectomy is still a question that requires more robust evidence for a definitive answer. Therefore, we conducted this study to determine the effectiveness of preoperative systemic therapy combined with gastrectomy and postoperative systemic therapy compared to systemic therapy alone for metastatic gastric cancer with the following research questions:

  1. Does the combination of neoadjuvant systemic therapy, gastrectomy, and adjuvant systemic therapy improve survival time for metastatic gastric cancer compared to systemic therapy alone?
  2. Is gastrectomy after neoadjuvant systemic therapy safe?
Being tested
Cytoreductive Gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytoreductive GastrectomyProcedure or surgery

    The patients undergo gastrectomy after 4 cycles of systemic therapy

Study groups in NCT06768463
Study groupRoleWhat they receive
Cytoreductive Gastrectomy After Systemic TherapyExperimentalAfter 4 cycles of systemic therapy, the patients with complete response, or partial response, or stable disease undergo gastretomy. After gastrectomy, the patients continue to use systemic therapy.
Receives: Procedure: Cytoreductive Gastrectomy
Systemic Therapy AloneNo interventionThe patients only use systemic therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median survival time

    the median length of time from the date of randomization to death from any cause or to the last follow-up for a surviving patient the median length of time from the date of randomization to death from any cause or to the last follow-up for a surviving patient

    Measured: 36 months after surgery

  2. Progression-free survival (PFS)

    Time interval from randomization to either radiological/clinical recurrence (Arm 1) or progression (Arm 2) or death from any cause. Patients who remained alive and without recurrence at the time of analysis or who are lost to follow-up will be censored at the date last seen

    Measured: 3 year after surgery

Secondary outcomes (8)
  1. Overall survival (OS

    the time interval from randomization to death from any cause. Patients who remained alive at the time of analysis or who are lost to follow-up will be censored at the date last seen and intention-to-treat analysis will be performed

    Measured: 3 year after surgery

  2. Cytoreductive completenes of peritonectomy (for Arm 1)

    The compleness of peritonectomy

    • CC-0: no peritoneal seeding visualized within the operative field
    • CC-1 indicates nodules persisting after cytoreduction less than 2.5 cm
    • CC-2 has nodules between 2.5 and 5 cm
    • CC-3 indicates nodules greater than 5 cm or a confluence of unresectable tumor nodule at any site within the abdomen or pelvis.

    Measured: within 30 days after surgery

  3. R0 resection rate (for Arm 1)

    Percentage of cases achiving R0 resection after cytoreductive surgery.

    Curability after conversion surgery (R0/R1/R2) defined as:

    • R2 surgery: macroscopically positive residual tumor at margins, invasive lesion, other metastatic lesions; or cytoreductive completeness of 1-3 when performing peritonectomy
    • R1 surgery: no R2 criteria; microscopically positive margins, or positive cytology lavage after gastrectomy, or finding of malignant lesion in the 3-month postoperative imaging
    • R0 surgery: no R1 or R2 surgery, and no finding of malignant lesion in thẻ 3-month postoperative imaging

    Measured: 3-month after conversion surgery

  4. Early complication rate (Arm 1)

    Rate of any complications happened intraoperative and 30-days post-operative, classified by Clavien - Dindo classification

    Measured: 30-day postoperative

  5. Late comlication rate (Arm 1)

    Rate of any complications happened after 30-days postoperative, classified by Clavien - Dindo classification

    Measured: 3 year after surgery

  6. Pathological response rate (Arm 1)

    proportion of patients achieving grade 2 or more according to the histological criteria of the Japanese Classification of Gastric Carcinoma

    Measured: 30-day postoperative

  7. Length of post-operative hospital stay

    Time from day of surgery until day of discharge

    Measured: 30-day postoperative

  8. Quality of life Quality of life Quality of life

    The European Organization for Research and Treatment (EORTC) of Cancer quality of life questionnaire (EORTC-QLQ C30)

    Measured: 1 year after surgery or after chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start1 Aug 2025
  3. Primary completion10 Jul 2027 (estimated)
  4. Study completion10 Dec 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cytoreductive Gastrectomy After Systemic Therapy For Limited Metastasis Gastric Cancer
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768463
Sponsor's protocol ID
CYGAS-GC
Acronym
CYGAS-GC
Status last verified
Jun 2025
First submitted
26 Dec 2024
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cytoreductive Gastrectomy in people with Metastatic Gastric Cancer and Gastric Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

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 20 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

Contact Vo D Long, Prof. (+84918133915, long.vd@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median survival time (time frame: 36 months after surgery). The study lists 2 primary outcomes in all. 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 27 Aug 2025.

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