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Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma (PLATANUS)

4. august 2026 opdateret af: National Cancer Center, Japan

Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma: A Randomized Phase 2 Investigator-Initiated Trial

To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

136

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Japan
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Rekruttering
        • Chiba Cancer Center
        • Kontakt:
          • Keiko Minashi, M.D.
          • Telefonnummer: +81-43-264-5431
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Rekruttering
        • Kyushu Cancer Center
        • Kontakt:
          • Yasue Kimura, M.D.
          • Telefonnummer: +81-92-541-3231
    • Gifu
      • Gifu, Gifu, Japan
        • Ikke rekrutterer endnu
        • Gifu University Hospital
        • Kontakt:
          • Akitaka Makiyama, M.D.
          • Telefonnummer: +81-58-230-6000
    • Gunma
      • Maebashi, Gunma, Japan
        • Ikke rekrutterer endnu
        • Gunma University Hospital
        • Kontakt:
          • Daisuke Takahari, M.D.
          • Telefonnummer: +81-27-220-7111
    • Hiroshima
      • Hiroshima, Hiroshima, Japan
        • Ikke rekrutterer endnu
        • Hiroshima University Hospital
        • Kontakt:
          • Kazuteru Tanabe
          • Telefonnummer: +81-82-257-5555
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • Rekruttering
        • St. Marianna University Hospital
        • Kontakt:
          • Yohei Kubota, M.D.
          • Telefonnummer: +81-44-977-8111
      • Yokohama, Kanagawa, Japan
        • Ikke rekrutterer endnu
        • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
        • Kontakt:
          • Mitsuhiro Furuta, M.D.
          • Telefonnummer: +81-45-520-2222
    • Kitaadachi-gun
      • Ina, Kitaadachi-gun, Japan
        • Ikke rekrutterer endnu
        • Saitama Prefectural Cancer Center
        • Kontakt:
          • Hiroki Hara, M.D.
          • Telefonnummer: +81-48-722-1111
    • Osaka
      • Osaka, Osaka, Japan
        • Ikke rekrutterer endnu
        • Osaka International Cancer Institute
        • Kontakt:
          • Kazuyoshi Yamamoto, M.D.
      • Takatsuki, Osaka, Japan
        • Rekruttering
        • Osaka Medical and Pharmaceutical University Hospital
        • Kontakt:
          • Toshifumi Yamaguchi, M.D.
          • Telefonnummer: +81-72-683-1221
    • Saitama
      • Hidaka, Saitama, Japan
        • Ikke rekrutterer endnu
        • Saitama Medical University International Medical Center
        • Kontakt:
          • Shinichi Sakuramoto, M.D.
          • Telefonnummer: +81-42-984-4111
    • Sunto-gun
      • Nagaizumi-chō, Sunto-gun, Japan
        • Ikke rekrutterer endnu
        • Shizuoka Cancer Center
        • Kontakt:
          • Takeshi Kawakami
          • Telefonnummer: +81-55-989-5222
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104-0045
      • Koto-Ku, Tokyo, Japan
        • Ikke rekrutterer endnu
        • Cancer Institute Hospital of JFCR
        • Kontakt:
          • Akira Oki, M.D.
          • Telefonnummer: +81-3-3520-0111
  • Sydkorea
      • Songpa-dong, Sydkorea
        • Ikke rekrutterer endnu
        • Asan Medical Center
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Sydkorea
        • Ikke rekrutterer endnu
        • National Cancer Center Korea
      • Suwon, Gyeonggi-do, Sydkorea
        • Ikke rekrutterer endnu
        • Ajou University Hospital
    • Seoul
      • Seocho, Seoul, Sydkorea
        • Ikke rekrutterer endnu
        • Seoul St. Mary'S Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 1) Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma at the study site. (For gastroesophageal junction adenocarcinoma, only patients classified as Siewert type II or type III who do not require surgery involving simultaneous thoracoabdominal incision are eligible.)
  • 2) Tumor tissue determined to be PD-L1 positive (CPS >= 5) based on pre-screening evaluation by the central laboratory.
  • 3) Diagnosis of cT3-4N1-3M0 disease according to the AJCC/UICC-TNM 8th edition based on assessments performed within 28 days prior to randomization (the same day of the week 4 weeks before the randomization date is acceptable; the same applies hereafter), with no prior systemic treatment. Pre-randomization laparoscopy is not mandatory, but if performed, no non-curative factors (including liver metastasis, peritoneal metastasis, other distant metastases, or positive peritoneal cytology (CY1)) should be observed.
  • 4) Judged by the investigator as capable of undergoing R0 resection.
  • 5) Age between 18 years and 80 years on the day of enrollment.
  • 6) ECOG performance status (PS) of 0 or 1.
  • 7) The most recent laboratory values obtained within 14 days prior to randomization meet all of the following (however, transfusion, recombinant human thrombopoietin, and administration of granulocyte colony-stimulating factor (G-CSF) within 14 days prior to blood collection are not permitted): (1) Neutrophil count >= 1500/mm^3 (2) Hemoglobin >= 9.0 g/dL (3) Platelet count >= 10 x 10^4/mm^3 (4) Total bilirubin <= 1.5 mg/dL (5) AST <= 100 U/L (6) ALT <= 100 U/L (7) Serum albumin >= 3.0 g/dL (8) Serum creatinine <= 1.5 mg/dL (9) APTT <= 60 s (10) PT-INR <= 1.5
  • 8) Females of childbearing potential should test negative for pregnancy test (serum or urine) within 7 days prior to randomization (the same day of the week is acceptable).
  • 9) Male patients and females of childbearing potential agree to use contraception from the time of provision of informed consent through a specified period after the last administration of study treatment (until at least 120 days after the last dose of HLX10 and at least 180 days after the last dose of study drug other than HLX10 (S-1 or oxaliplatin)).
  • 10) Written informed consent for study participation has been obtained from the patient.

Exclusion Criteria:

  • 1) Presence of another active malignancy within 5 years prior to enrollment or concurrently. Patients with cured, localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, non-invasive prostate cancer, non-invasive cervical cancer, and non-invasive breast cancer are permitted.
  • 2) Patients scheduled to undergo organ transplantation or bone marrow transplantation.
  • 3) Myocardial infarction and/or uncontrolled arrhythmia (including QTc interval >= 450 ms in males or >= 470 ms in females) occurring within 6 months prior to randomization (QTc interval calculated using Fridericia's formula).
  • 4) Cardiac dysfunction classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) < 50 percent on echocardiography.
  • 5) Positive for any of the following: HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA is measured only if HCV antibody is positive).
  • 6) HBs antigen negative, HBs antibody and/or HBc antibody positive, and quantitative HBV-DNA detectable (patients are not excluded if HBV-DNA is below the limit of detection).
  • 7) Active tuberculosis.
  • 8) Interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and/or severe pulmonary dysfunction that may interfere with evaluation and management of suspected drug-related pulmonary toxicity.
  • 9) Known active or suspected autoimmune disease, excluding patients whose disease is stable at randomization and who do not require systemic immunosuppressive therapy.
  • 10) Patients who received live vaccination within 28 days prior to randomization, except for inactivated virus vaccines used for seasonal influenza prophylaxis.
  • 11) Patients who require systemic corticosteroids (a therapeutic dose of > 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days prior to randomization or during the study period. However, in the absence of active autoimmune disease, patients are permitted to use steroids at a dose of <= 10 mg/day prednisone or equivalent, or inhaled steroids, or adrenal hormone replacement therapy.
  • 12) Patients who have an active infection requiring systemic anti-infective treatment within 14 days prior to randomization, except for prophylactic antibiotic treatment (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease).
  • 13) Prior treatment with other antibody or drug therapies for immune checkpoint blockade, such as PD-1, PD-L1, or CTLA-4 therapy.
  • 14) Patients currently receiving other clinical study treatment, or for whom the planned start of treatment in this study is < 14 days from completion of the prior clinical study treatment.
  • 15) History of severe hypersensitivity to the monoclonal antibody or any component of the study drug.
  • 16) History of psychotropic drug abuse or drug dependence.
  • 17) Patients with a disease that may increase the risk associated with study participation and use of the study drug, or with other severe acute or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SOX+HLX10
Neoadjuvant treatment period: SOX+HLX10 Surgery Postoperative adjuvant treatment period: HLX10
Medicin: serplulimab
Patients receive perioperative treatment with S-1 plus oxaliplatin (SOX) in combination with Serplulimab.
Andre navne:
  • oxaliplatin
  • S-1 (tegafur/gimeracil/oteracil)
Placebo komparator: SOX+Placebo
Neoadjuvant treatment period: SOX + Placebo Surgery Postoperative adjuvant treatment period: SOX
Medicin: Placebo
Patients receive perioperative treatment with S-1 plus oxaliplatin (SOX) in combination with placebo.
Andre navne:
  • oxaliplatin
  • S-1 (tegafur/gimeracil/oteracil)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pathological complete response (pCR) rate by central pathology review
Tidsramme: Approximately 4-5 months after randomization (after surgery)
In the ITT population, this is defined as the proportion of subjects with complete disappearance of the tumor based on central pathology review.
Approximately 4-5 months after randomization (after surgery)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Investigator-assessed event-free survival
Tidsramme: From randomization up to 28 months
In the ITT population, this is defined as the time from the date of randomization to the first occurrence of any of the following events.
From randomization up to 28 months
Overall survival
Tidsramme: From randomization up to 28 months
In the ITT population, OS is defined as the time from the date of randomization to the date of death from any cause.
From randomization up to 28 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Center, Japan

Efterforskere

  • Ledende efterforsker: Ken Kato, M.D., Ph.D., National Cancer Center, Japan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2026

Primær færdiggørelse (Anslået)

30. november 2028

Studieafslutning (Anslået)

30. juni 2029

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCCH2414/ATLAS2502

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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