RecruitingPhase 2NCT06939452

A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression


Sponsor

Yongxu Jia

Enrollment

37 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three anti-cancer drugs — anlotinib (a targeted therapy that blocks tumor blood vessel growth), TQB2450 (an immunotherapy), and SOX chemotherapy (oxaliplatin plus tegafur/gimeracil/oteracil) — as a first-line treatment for people with advanced gastric or gastroesophageal junction cancer that has low levels of a protein called PD-L1. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced or metastatic stomach or gastroesophageal junction cancer that is HER2-negative - You have not previously received treatment for this metastatic disease (though prior surgery/chemo/radiation for earlier-stage disease is allowed if completed more than 6 months ago) - Your general health is good and your organ function is within acceptable ranges - You have at least one measurable tumor **You may NOT be eligible if...** - You have already received first-line chemotherapy for metastatic disease - Your organ function (liver, kidneys, blood counts) is significantly impaired - You have active uncontrolled infections, autoimmune conditions, or significant heart problems - Your performance status is too low for chemotherapy 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

DRUGanlotinib +TQB2450 + Oxaliplatin+S-1

Anlotinib: 10mg, po, d1-14,q3w,until disease progression or unacceptable toxicity. TQB2450: 1200mg, iv, d1, q3w,until disease progression or unacceptable toxicity. Oxaliplatin: 130mg/㎡, iv, d1,6 cycles. S-1:40mg, po, bid, d1\~14,6 cycles.


Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06939452