RecruitingPhase 2Phase 3NCT05699655

Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer

Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer: Randomized Control, Open, Multicenter Trial-2 (TAOS-3B-Trial-2)


Sponsor

Fujian Cancer Hospital

Enrollment

130 participants

Start Date

May 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding tislelizumab (an immunotherapy) and apatinib (a targeted blood vessel-blocking drug) to standard chemotherapy (oxaliplatin plus S1) before surgery improves outcomes for patients with locally advanced gastric (stomach) cancer that is particularly large or has spread to nearby lymph nodes. **You may be eligible if...** - You are 18–70 years old with locally advanced gastric adenocarcinoma confirmed by biopsy - Your cancer is classified as large Borrmann III, Borrmann IV, or bulky N-positive (meaning significant lymph node involvement) - You have not previously received surgery, chemotherapy, radiation, or immunotherapy for this cancer - Your expected survival is more than 6 months **You may NOT be eligible if...** - You have cancer that has spread to the peritoneum (lining of the abdomen) or distant organs - 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

DRUGTislelizumab

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 4 cycles. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.

DRUGapatinib

Participants will receive apatinib, 250mg, qd,every 3 weeks for 3 weeks

DRUGoxaliplatin

Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.

DRUGS-1

Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.


Locations(1)

Fujian cancer hospital

Fuzhou, Fujian, China

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NCT05699655