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XELOX Combined With Fruquintinib and Sintilimab Regimen Conversion Therapy for Gastric Cancer/Gastroesophageal Junction Adenocarcinoma Only With Liver and/or Retroperitoneal Lymph Node Metastasis, a Prospective Single-arm, Multicenter Study

NCT06091423 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-11-30

No results posted yet for this study

Summary

Gastric cancer is the third leading cause of morbidity and mortality among malignant tumors in China, and less than 30% of patients can be cured by surgery. Liver metastasis, retroperitoneal lymph node metastasis and peritoneal metastasis are the most common metastatic sites of gastric cancer, which are also the important causes of death. Improve the conversion of oligonucleotides transfer patients resection rate, prolonged progression-free survival of these patients, is an important direction to improve survival of patients with advanced gastric cancer;

This study was a prospective, single-arm, multi-center clinical study. We plan to treat patients with gastric cancer/gastroesophageal junction adenocarcinoma with liver and/or retroperitoneal lymph node metastasis only with XELOX regimen + fruquinitinib + sintilimab for 4-6 cycles before surgery/ablation conversion therapy to achieve tumor-free status as far as possible. To explore the value of conversion therapy in patients with intrahepatic oligometastasis of gastric cancer.

Conditions

  • Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

XELOX combined with Fruquintinib and Sintilimab

XELOX:Capecitabine：800mg/m2, po, bid, d1-14。Oxaliplatin：130mg/m2，ivgtt 2-6h，d1，q3w; Fruquintinib: 5 mg/d，qd po，d1-14，q3w; Sintilimab: 200mg d1, q3w

Sponsors & Collaborators

  • Xiaofeng Chen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2025-11-25
Completion
2026-11-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091423 on ClinicalTrials.gov