RecruitingPhase 2NCT06091423

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

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 ( FISSION Study )


Sponsor

Xiaofeng Chen

Enrollment

43 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of drugs — XELOX (capecitabine + oxaliplatin), fruquintinib (a drug that blocks tumor blood vessel growth), and sintilimab (an immunotherapy drug) — as a 'conversion therapy' for people with advanced stomach or gastroesophageal junction cancer that has spread only to the liver and/or specific abdominal lymph nodes. The aim is to shrink the cancer enough that surgery becomes possible. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed HER2-negative stomach or gastroesophageal junction adenocarcinoma - Your cancer has spread only to the liver (5 or fewer lesions, each under 5 cm) and/or to specific nearby lymph nodes (retroperitoneal) - You have at least one measurable tumor on imaging - You have not previously received VEGFR-targeted drugs or PD-1/PD-L1 immunotherapy **You may NOT be eligible if...** - Your cancer has spread to other distant organs beyond the liver and retroperitoneal lymph nodes - You have more than 5 liver metastases or a single lesion larger than 5 cm - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXELOX 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


Locations(1)

Jiangsu Province Hospita

Nanjin, China

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NCT06091423