RecruitingNot ApplicableNCT06158919

A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer

A Phase II Clinical Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer

Sponsor

Fudan University

Enrollment

58 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer/Adenocarcinoma of Esophagogastric Junction

Summary

This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC. Eligible enrolled patients received 6 cycles of combined treatment with fuquinitinib combined with PD-1 inhibitor and chemotherapy (XELOX/SOX) regimen. Maintenance treatment was fuquinitinib combined with PD-1 inhibitor and Teghio/capecitabine until disease progression or toxicity became intolerable. The longest duration of PD-1 inhibitor treatment is 24 months.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of PD-1 immunotherapy, fruquintinib (a drug that blocks blood vessel growth in tumors), and chemotherapy as a first-line treatment for patients with advanced or metastatic stomach cancer or cancer at the gastroesophageal junction that does not have the HER2 protein. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with advanced or metastatic stomach cancer or gastroesophageal junction cancer, confirmed by pathology - Your tumor does not express the HER2 protein (HER2-negative) - You have not yet received treatment for advanced disease - Your overall health and organ function meet the required criteria **You may NOT be eligible if...** - You have already received treatment for advanced gastric or GEJ cancer - Your tumor is HER2-positive - Your health or organ function does not meet the required thresholds - You have conditions that make chemotherapy or immunotherapy unsafe 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

DRUGFruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine

Combined treatment period: A total of 6 cycles of combined treatment Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w SOX : Oxaliplatin 130mg/m2 iv.gtt d1, Teysuno 40mg/m2 p.o.b.i.d. d1\~ 14q3w. Or XELOX regimen: oxaliplatin 130mg/m2 iv.gtt d1 Capecitabine 1000mg/m2 p.o. b.i.d. d1\~ 14q3w. Maintenance treatment period: Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w Teysuno 40mg/m2 p.o.b.i.d. d1\~14 q3w or Capecitabine 1000mg/m2 p.o.b.i.d. d1\~14 q3w. Maintenance of treatment until disease progression or toxicity becomes intolerable.

Locations(1)

Fudan University ShangHai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06158919