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Advanced Gastric CarcinomaPhase 3NCT05270824

Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma

A Phase 3 study testing radical surgery after neoadjuvant immunotherapy and radical surgery after neoadjuvant chemotherapy in people with Advanced Gastric Carcinoma and CD8+ Tumor Infiltrating Lymphocytes, run by Fujian Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Focusing on the clinical question of whether patients with advanced gastric cancer can benefit from immunotherapy, this project intends to detect the degree of CD8+ tumor-infiltrating lymphocyte infiltration in patients with advanced gastric cancer before and after receiving neoadjuvant combined immunotherapy and… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
radical surgery after neoadjuvant immunotherapy and radical surgery after neoadjuvant chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
1 Mar 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 stage ≥cT2 or N+；
  • Patients who have not received other treatments such as surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy；
  • Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)；
  • Estimated survival time was over 3 months；
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  • No serious heart, lung and liver dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;；
  • The major organs are functioning normally and meet the following criteria:
  • 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)， b. ALT and AST<2.5ULN，GPT≤1.5×ULN； c. Cr≤1ULN，Ccr >60ml/min 9. 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 10. Did not participate in other clinical studies before and during treatment 11. 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；
  • Contraindications to surgery and chemotherapy, or whose physical condition and organ function do not allow for major abdominal surgery
  • Distant metastases；
  • Accompanied by severe heart, lung, liver and kidney diseases; neurological and mental diseases; jaundice and accompanied by severe infection；
  • Women during pregnancy or breast-feeding；
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  • Patients with high blood pressure that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
  • Suffering from coronary heart disease of grade I or above, arrhythmia (including QTc interval prolongation > 450 ms in men and > 470 ms in women), and cardiac insufficiency;
  • Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: patients with locally active ulcer lesions, fecal occult blood (++), and history of melena and hematemesis within 2 months; patients with abnormal coagulation function (INR> 1.5, APTT>1.5 ULN);
  • Patients with a history of cardiovascular and cerebrovascular diseases who are still taking oral thrombolytics or anticoagulants;
  • Patients with positive urine protein (urinary protein test 2+ or above, or 24-hour urine protein quantitative> 1.0g;
  • Multiple factors affect oral drugs (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
  • Those who have allergic reactions to the drugs in this study;
  • The researcher believes that it is not suitable for inclusion.

About this study

Official title: Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma : a Single Randomized Controlled Trial

Focusing on the clinical question of whether patients with advanced gastric cancer can benefit from immunotherapy, this project intends to detect the degree of CD8+ tumor-infiltrating lymphocyte infiltration in patients with advanced gastric cancer before and after receiving neoadjuvant combined immunotherapy and neoadjuvant therapy alone. To explore the evolving nature of tumor immune response before and after neoadjuvant therapy for gastric cancer, and quantitatively present it through chemical immunohistochemical techniques to achieve a more accurate diagnosis and treatment and improve the long-term efficacy of patients.

Being tested
radical surgery after neoadjuvant immunotherapy, radical surgery after neoadjuvant chemotherapy

What participants receive

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

  • radical surgery after neoadjuvant immunotherapyCombination product

    A total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy.

  • radical surgery after neoadjuvant chemotherapyCombination product

    A total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy.

Study groups in NCT05270824
Study groupRoleWhat they receive
radical surgery after neoadjuvant immunotherapy (albumin Paclitaxel + Seggio + PD-1 inhibitor)ExperimentalAfter randomization, patients received radical surgery after the neoadjuvant immunotherapy (albumin Paclitaxel + Seggio + PD-1 inhibitor)
Receives: Combination Product: radical surgery after neoadjuvant immunotherapy
radical surgery after neoadjuvant chemotherapy (albumin Paclitaxel + Seggio)Active comparatorAfter randomization, patients received radical surgery after neoadjuvant chemotherapy (albumin Paclitaxel + Seggio)
Receives: Combination Product: radical surgery after neoadjuvant chemotherapy

What is being measured

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

  1. The number of CD8+ tumor-infiltrating lymphocytes in tumor tissue and adjacent tissue before and after treatment

    Changes in the number of CD8+ tumor-infiltrating lymphocytes in the tumor and adjacent tissues of the experimental group before and after the surgery compared with the control group.

    Measured: 6 months

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Complete response (CR) + partial response (PR)

    Measured: 6 months

  2. Disease-free survival (DFS)

    Time from study entry to disease recurrence or patient death due to disease progression

    Measured: 2 years

  3. Overall survival (OS)

    Time from study entry to death from any cause.

    Measured: 2 years

  4. Therapeutic drug safety

    Adverse events (AEs), serious adverse events (SAEs), drug-related AEs, SAEs, and class-specific AEs (eg, hypertension, proteinuria, and hand-foot syndrome)

    Measured: 6 months

  5. Surgical safety

    R0 resection rate, operative mortality, surgical complications (bleeding, anastomotic leakage, incision infection), reoperation rate, hospital stay, etc.

    Measured: 6 months

Timeline

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

  1. First posted8 Mar 2022
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Mar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05270824
Sponsor's protocol ID
FUGES-025
Status last verified
Feb 2022
First submitted
22 Feb 2022
Last updated
8 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing radical surgery after neoadjuvant immunotherapy and radical surgery after neoadjuvant chemotherapy in people with Advanced Gastric Carcinoma and CD8+ Tumor Infiltrating Lymphocytes, 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 14 inclusion and 14 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 8 Mar 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?

The number of CD8+ tumor-infiltrating lymphocytes in tumor tissue and adjacent tissue before and after treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05270824.

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 8 Mar 2022; AzTrials last refreshed its copy on 28 Oct 2026.

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