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A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction

20. maj 2026 opdateret af: Hebei Medical University Fourth Hospital
Evaluating the efficacy and safety of SHR-1701 combined with chemotherapy for the perioperative treatment of locally advanced resectable Siewert type II adenocarcinoma of the esophagogastric junction.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

38

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Hebei
      • Shijiazhuang, Hebei, Kina
        • The Fourth Hospital of Hebei Medical University
        • Kontakt:

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.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- / IHC 1+ / IHC -); 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria); 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:

  1. routine blood tests:

    1. HB≥90g/L;
    2. ANC≥1.5×109/L;
    3. PLT≥100×109/L;
  2. biochemical examination:

    1. ALT and AST<2.5ULN(liver metastasis: ALT and AST<5ULN);
    2. TBIL≤1.5ULN;
    3. Creatinine ≤1.5ULN; 9.Left ventricular ejection fraction is >50%; 10.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; 11. Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.

Exclusion Criteria:

  1. Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);
  2. Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;
  3. Cardia or pyloric obstruction;
  4. Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;
  5. Known hypersensitivity to any monoclonal antibody or component of a chemotherapy agent (such as tegafur or albumin-bound paclitaxel) (history of Grade 3 or higher hypersensitivity reaction);
  6. Previous exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, or CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
  7. Receipt of an attenuated live vaccine within 4 weeks prior to the first dose of study treatment, or planned administration during the study period;
  8. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the start of study treatment (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency);
  9. History of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose;
  10. Congenital or acquired immunodeficiency (e.g., HIV infection);
  11. The investigator determines that the subject has other factors that may affect the study results or lead to the premature termination of the study, such as alcohol abuse, substance abuse, other serious illnesses (including mental disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that may compromise the subject's safety;
  12. Pregnant or breastfeeding women;
  13. Evidence of medical history or disease that may interfere with trial results or prevent the subject from participating in the study throughout its duration, abnormal treatment or laboratory test results, or other circumstances deemed by the investigator to make the subject unsuitable for enrollment; or other potential risks identified by the investigator that render the subject unsuitable for participation in this 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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SHR-1701+SOX
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pathological Complete Response(pCR)
Tidsramme: 1-year
No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
1-year
R0 resection rate
Tidsramme: 1-year
The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
1-year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major Pathological Response(MPR)
Tidsramme: 1-year
Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.
1-year
PFS(Progression-Free Survival)
Tidsramme: 3 years
The time from the start of treatment until tumor progression or death from any cause.
3 years
OS(Overall Survival )
Tidsramme: 3 years
Time from enrollment to death from any cause. For subjects who were still alive at the time of the last follow-up, their overall survival was censored on the date of the last follow-up.
3 years

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Ziqiang Tian, Hebei Medical University Fourth Hospital

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 (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

31. marts 2028

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AZL-EJC

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Siewert Type II Adenocarcinoma of the Esophagogastric Junction

Kliniske forsøg med SHR-1701+SOX

Abonner