RecruitingPhase 2NCT06451211

Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)


Sponsor

Sun Yat-sen University

Enrollment

53 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining immunotherapy with chemotherapy before surgery (called neoadjuvant treatment) is effective for people with a particularly aggressive form of stomach cancer — specifically a diffuse, leather-bottle type (Borrmann type 4) or a very large tumor (over 8 cm). **You may be eligible if...** - You are aged 18–70 and have been diagnosed with stomach cancer confirmed by biopsy - Your cancer is a diffuse/scirrhous type (Borrmann type 4) or a large type 3 tumor over 8 cm - Your cancer has not spread to the abdominal lining (peritoneum) - You are in good general health (able to carry out daily activities) - You have not had any prior cancer treatment **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You have previously received chemotherapy, radiation, or immunotherapy - You are pregnant or breastfeeding - You cannot take medications by mouth 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

Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants

DRUGOxaliplatin

Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants

DRUGS-1

S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants

DRUGCapecitabine

Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06451211


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