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

Last updated: September 11, 2024
Sponsor: Guihua Wang
Overall Status: Active - Recruiting

Phase

4

Condition

Stomach Cancer

Gastric Cancer

Digestive System Neoplasms

Treatment

Proximal radical gastrectomy

Total radical gastrectomy

Clinical Study ID

NCT06597227
2024-S029
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • To be eligible to participate in this study, all patients must meet all thefollowing criteria:
  1. The subjects voluntarily joined the study and were able to sign the informedconsent with good compliance;

  2. Age 18-75 years old (at the time of signing the informed consent), both maleand female;

  3. Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consentto neoadjuvant therapy. Investigators assessed the lesion as resectable orpotentially resectable;

  4. Have not received systematic treatment for the current disease, includinganti-tumor chemoradiotherapy/immunotherapy;

  5. ECOG score 0-1;

  6. Expected survival ≥6 months;

  7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distantmetastasis;

  8. The major organs function well and meet the following criteria:

  9. Blood routine examination (no blood transfusion within 14 days, nohematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L;Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;

  10. Biochemical examination: alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serumcreatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;

  11. Coagulation function: activated partial thromboplastin time (APTT),International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;

  12. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;

  13. Assessed with adequate organ function by doctors. 9. Fertile subjects must useappropriate methods of contraception during the study period and within 120days after the end of the study, have a negative serological pregnancy testwithin 7 days prior to study enrollment, and must be non-lactating subjects.

Exclusion

Exclusion Criteria:

  • To be eligible to participate in this study, all patients must meet all thefollowing criteria:
  1. The subjects voluntarily joined the study and were able to sign the informedconsent with good compliance;

  2. Age 18-75 years old (at the time of signing the informed consent), both maleand female;

  3. Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consentto neoadjuvant therapy. Investigators assessed the lesion as resectable orpotentially resectable;

  4. Have not received systematic treatment for the current disease, includinganti-tumor chemoradiotherapy/immunotherapy;

  5. ECOG score 0-1;

  6. Expected survival ≥6 months;

  7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distantmetastasis;

  8. The major organs function well and meet the following criteria:

  9. Blood routine examination (no blood transfusion within 14 days, nohematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L;Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;

  10. Biochemical examination: alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serumcreatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;

  11. Coagulation function: activated partial thromboplastin time (APTT),International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;

  12. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;

  13. Assessed with adequate organ function by doctors. 9. Fertile subjects must useappropriate methods of contraception during the study period and within 120days after the end of the study, have a negative serological pregnancy testwithin 7 days prior to study enrollment, and must be non-lactating subjects.

Study Design

Total Participants: 404
Treatment Group(s): 2
Primary Treatment: Proximal radical gastrectomy
Phase: 4
Study Start date:
March 01, 2024
Estimated Completion Date:
December 30, 2028

Study Description

Gastric cancer is one of the most common malignant tumors in China, and its morbidity and mortality rank among the top three for a long time.How to improve the survival rate of patients with advanced gastric cancer is the key to improve the prognosis.At present, neoadjuvant chemotherapy combined with immunosuppressants has a higher pathologic complete response (pCR) rate, reduce the clinical stage of tumors and improve the resection rate of radical surgery.Some studies have suggested that preserving partial gastric lymph nodes may enhance immunotherapy efficacy.Proximal radical gastrectomy versus total radical gastrectomy can reduce the scope of surgical resection and preserve some lymph nodes, which may contribute to long-term survival and improve postoperative quality of life of patients. It is expected to translate the short-term benefit of neoadjuvant immunotherapy into the benefit of patient overall survival (OS) rate.At the same time, our previous studies have shown that the methylation level of PD-L1 K162 can be used as a new indicator to predict the sensitivity of anti-PD -(L)1 immunotherapy, which is expected to be further confirmed in this clinical trial.Therefore, we plan to conduct a comparative study on the effectiveness and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy for locally advanced upper gastric cancer, which is expected to propose new changes in surgical methods for gastric cancer and a new indicator for screening the advantages of gastric cancer immunotherapy in the era of immunotherapy.

Connect with a study center

  • Tongji Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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