RecruitingPhase 2NCT05536102

The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)

A Single-arm, Open-label, Multicenter Phase 2 Study to Evaluate XELOX + Tislelizumab in Combination With Doxorubicin Hydrochloride Liposome Injection (XELOX+PD-1+PLD)as Neoadjuvant Therapy for Resectable Gastric Cancer


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

38 participants

Start Date

Sep 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a signle-arm, multi-center, open-lable, phase II study. The objective is to evaluate the effectiveness and safety of tislelizumab + oxaliplatin + capecitabine + PLD in the neoadjuvant treatment of resectable gastric adenocarcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (called the Liding Study) is testing whether adding an immunotherapy drug (tislelizumab) and a targeted drug (pegylated liposomal doxorubicin, or PLD) to standard chemotherapy (XELOX) before surgery improves outcomes for patients with resectable (operable) stage III stomach cancer. The aim is to shrink the tumor before surgery to improve the chance of a complete cure. **You may be eligible if:** - You are 18–75 years old - You have been diagnosed with stage III stomach (gastric) adenocarcinoma confirmed by biopsy - Your cancer is HER2-negative and PD-L1-positive (specific lab markers on the tumor) - Your overall health and organ function are adequate for major surgery - Your heart function is normal (ejection fraction ≥50%) **You may NOT be eligible if:** - Your cancer has spread to distant organs or lymph nodes beyond what is classified as stage III - Your cancer is HER2-positive - You have serious heart, liver, kidney, or blood count issues - You have autoimmune disease or are on immunosuppressive drugs 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

DRUGPLD

20mg/m2, day 1, q3w

DRUGOxaliplatin

130 mg/m2, day 1, q3w

DRUGCapecitabine

1000 mg/m2, days 1-14, q3w

DRUGTislelizumab

200 mg, day 1, q3w


Locations(1)

Shanghai General Hospital

Shanghai, China

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NCT05536102


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