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Efficacy and safety of S-1 plus oxaliplatin combined with apatinib and camrelizumab as neoadjuvant therapy for patients with locally advanced gastric or gastroesophageal junction adenocarcinoma: a protocol for a single-arm phase II trial

  • 0Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan, China.
Updates in Surgery +

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December 31, 2024

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December 31, 2024

View abstract on PubMed

Summary

This summary is machine-generated.

This study evaluates the SOXAC regimen (S-1, oxaliplatin, apatinib, and camrelizumab) as neoadjuvant therapy for advanced gastric cancer. It assesses efficacy and safety, aiming to improve treatment outcomes for this significant malignancy.

Area Of Science

  • Oncology
  • Gastroenterology
  • Clinical Trials

Background

  • Gastric cancer is a leading cause of cancer death globally.
  • Neoadjuvant therapy for advanced gastric cancer requires novel treatment strategies.
  • The combination of chemotherapy, targeted therapy, and immunotherapy in neoadjuvant settings is underexplored.

Purpose Of The Study

  • To evaluate the efficacy and safety of the SOXAC regimen (S-1 plus oxaliplatin, apatinib, and camrelizumab) as neoadjuvant therapy for locally advanced gastric or gastroesophageal junction adenocarcinoma.
  • To determine the rates of major pathological remission (MPR) and pathological complete response (pCR).
  • To assess objective response rate (ORR), R0 resection, and safety outcomes.

Main Methods

  • A single-arm, open-label, phase II clinical trial.
  • Patients with locally advanced gastric or GEJ adenocarcinoma received neoadjuvant SOXAC therapy followed by surgery.
  • Postoperative adjuvant therapy with SOXC was administered.

Main Results

  • Primary endpoint: Major pathological remission (MPR) rate.
  • Secondary endpoints: Pathological complete response (pCR) rate, R0 resection rate, objective response rate (ORR), and safety.
  • Exploration of biomarker correlations with treatment efficacy.

Conclusions

  • The SOXAC regimen is being investigated as a novel neoadjuvant approach for gastric cancer.
  • This trial aims to establish the safety and efficacy of combining chemotherapy, targeted agents, and immune checkpoint inhibitors.
  • Findings may inform future treatment strategies for locally advanced gastric and GEJ adenocarcinoma.

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