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Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2NCT06764251

Tislelizumab Combined with SOX Regimen in the Treatment of Locally Advanced Gastric Cancer/gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Tislelizumab + SOX in people with Gastric/Gastroesophageal Junction Adenocarcinoma, run by Liaoning Cancer Hospital & Institute.

Not yet recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This study is to evaluate the efficacy of neoadjuvant long-term treatment with tislelizumab in combination with SOX in the treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Tislelizumab + SOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
30 Dec 2024to 31 Mar 2028
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to participate in this study, able to sign the informed consent form, and with compliance;
  • No gender restriction, aged ≥18 and ≤70 years (at the time of signing the informed consent form);
  • ECO score of 0-1;
  • Estimated survival ≥6 months;
  • HER-2 negative;
  • Central laboratory confirmed PD-L1 expression in the, with a combined positive score (CPS) ≥1;
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  • Histological and radiological assessment confirmed as advanced gastric cancer (GC) or gastroesal junction (GEJ) adenocarcinoma, with a clinical stage of cT3-T4aN M0;
  • Pre-enrollment by the attending physician to determine eligibility for R0 resection with curative intent;
  • Good cardiac function. Patients with underlying ischemic, valvular disease, or other severe heart disease should have a preoperative assessment by a cardiologist if there are clinical indications;
  • No prior cytotoxic or targeted, no prior partial or complete esophagogastric tumor resection;
  • Negative for hepatitis B surface antigen (HBsAg) and hepatitis core antibody (HBcAb). If HBsAg is positive or HBcAb is positive, then the hepatitis B virus deoxyribonucleic acidHBV-DNA) must be <1000 copies/mL or <200 IU/mL or <the upper limit of normal (ULN) at research center to be eligible;
  • Negative for hepatitis C virus (HCV) antibody;
  • Normal major organ function, as defined by the criteria (within 14 days before the first dose, without transfusions, albumin, recombinant human thrombopoietin, or colony-stulating factor (CSF) treatment): Blood routine examination: Hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC ≥1.5×109/L; platelets (PLT) ≥80×109/L; Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN liver metastasis); total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for Gilbert's syndrome); seruminine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60mL/min; Coagulation function: Activated partialboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN; Dpler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%; Normal thyroid function, defined as thyroid-stimulating hormone (T) within the normal range. If baseline TSH is out of range, patients with total T3 (or FT3) and FT4 within the normal range also be included; Clinical judgment by the doctor that organ function is sufficient.
  • Fertile subjects must use appropriate contraception during the study and for 20 days after the study ends, have a negative serum pregnancy test within 7 days before enrollment, and must not be breastfeeding

Who cannot join

  • Have had or simultaneously have other active malignant tumors within 5 years. Cured localized tumors, as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast in situ, are eligible;
  • Patients who are preparing for or have previously undergone organ or bone marrow transplantation;
  • Have ≥2 grade myocardial ischem or myocardial infarction, arrhythmia (QTc ≥470ms), and ≥2 grade congestive heart failure (New York Heart AssociationNYHA] classification);
  • Human immunodeficiency virus (HIV) infection;
  • Have active pulmonary tuberculosis;
  • Have a history or current presence interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary dysfunction, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity;
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  • Have known active or suspected autoimmune diseases, except those in a stable state at the time of enrollment (not requiring systemic immunospressive therapy);
  • Have received live vaccine treatment within 28 days before the first dose; seasonal flu vaccines are not included;
  • Have received or need receive systemic corticosteroids (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days before the dose or during the study. However, the following cases are allowed: patients with no active autoimmune diseases can use topical or inhaled corticosteroids, or hormone replacement therapy with a dose ≤ 10 mg/day prednisone equivalent dose;
  • Have any active infection that requires systemic anti-infective within 14 days before the first dose; prophylactic antibiotic treatment (e.g., for urinary tract infections or chronic obstructive pulmonary disease) is not;
  • Have previously received other antibodies/drugs targeting immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.;
  • Are currently receiving other clinical study treatments, or the time between the end of the previous clinical study treatment and the planned start of this study treatment is less than14 days;
  • Have a known severe allergic history to any monoclonal antibody or excipients of the study drug;
  • Have a history of psychiatric drug abuse or drug addiction; patients who have stopped drinking alcohol can be enrolled; According to the investigator's judgment, patients with serious concomitant that endanger the safety of the subjects or affect the completion of the study, or patients who are deemed unsuitable for enrollment for other reasons

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zheng Zhichao contact

86-024-24315679

drzhengzhichao@126.com

About this study

Official title: A Single-centre Phase II Clinical Study of Tislelizumab Combined with SOX Regimen in the Treatment of Locally Advanced Gastric Cancer/gastroesophageal Junction Adenocarcinoma

This study is to evaluate the efficacy of neoadjuvant long-term treatment with tislelizumab in combination with SOX in the treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma.

Being tested
Tislelizumab + SOX

What participants receive

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

  • Tislelizumab + SOXDrug

    tislelizumab combined with SOX

Study groups in NCT06764251
Study groupRoleWhat they receive
Tislelizumab + SOXExperimentalNot described
Receives: Drug: Tislelizumab + SOX

What is being measured

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

  1. Pathologic complete response rate (pCR)

    Measured: 3 week

Secondary outcomes (9)

  1. The R0 resection rate after radical operation

    Measured: 1 year

  2. Major Pathological response (MPR) after radical operation

    Measured: From baseline to after radical operation

  3. Event Free Survival Rate from baseline to 1 year

    Measured: from baseline to 1 year

  4. Overall Survival rate from baseline to 1 year

    Measured: From baseline to 1 year

  5. Disease-related treatment failure rate from baseline to 1 year

    Measured: From baseline to 1 year

  6. Objective response rate from baseline to 1 year

    Measured: From baseline to 1 year

  7. Disease control rate from baseline to 1year

    Measured: From baseline to 1year

  8. Correlation between PD-L1 expression, TMB level and T cell subsets in tumour tissue samples and efficacy.

    Measured: 6 week

  9. The safety from baseline to 1year

    Measured: From baseline to 1year

Timeline

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

  1. First posted8 Jan 2025
  2. Study start30 Dec 2024 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06764251
Sponsor's protocol ID
NeoGC-01
Status last verified
Dec 2024
First submitted
17 Dec 2024
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab + SOX in people with Gastric/Gastroesophageal Junction Adenocarcinoma, run by Liaoning Cancer Hospital & Institute.

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 Jan 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Zheng Zhichao (86-024-24315679, drzhengzhichao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response rate (pCR) (time frame: 3 week). 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 NCT06764251.

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 Jan 2025.

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