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NCT06597227Toboroz

Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy

Comparison of Clinical Efficacy of Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After SOX Combined With Anti-PD-1 Neoadjuvant Therapy：a Prospective, Multi-center, Randomised，Controlled Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 27.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
404 (tervezett)
Első benyújtás
2024. szept. 5.
Kezdés
2024. márc. 1.
Elsődleges befejezés
2026. dec. 30.
Fő szponzor
Guihua Wang
NCT-szám
NCT06597227

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 404
  • 2024. márc. 1. és az elsődleges befejezés (2026. dec. 30.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Laborértékek

  • To be eligible to participate in this study, all patients must meet all the following criteria:
    • The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
    • Age 18-75 years old (at the time of signing the informed consent), both male and female;
    • Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;
    • Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
    • ECOG score 0-1;
    • Expected survival ≥6 months;
    • Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
    • The major organs function well and meet the following criteria:
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    • Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;
    • Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;
    • Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
    • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
    • Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.

Kiket keres a vizsgálat

  • To be eligible to participate in this study, all patients must meet all the following criteria:
    • The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
    • Age 18-75 years old (at the time of signing the informed consent), both male and female;
    • Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;
    • Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
    • ECOG score 0-1;
    • Expected survival ≥6 months;
    • Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
    • The major organs function well and meet the following criteria:
    • <!-- -->
    • Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;
    • Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;
    • Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
    • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
    • Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.

Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Tongji Hospital, Huazhong University of Science and TechnologyWuhanKínaToboroz

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