RecruitingPhase 2NCT05687357

Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma

Tislelizumab in Combination With Pre-operative Chemoradiotherapy Versus SOC for Patients With Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Multicenter, Randomized, Open-label, Phase IIB Trial


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

140 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to treating locally advanced stomach or gastroesophageal junction cancer (cancer where the stomach meets the food pipe): the standard chemotherapy approach before surgery versus adding an immunotherapy drug (tislelizumab) combined with radiation before surgery. **You may be eligible if...** - You have locally advanced stomach or gastroesophageal junction cancer (adenocarcinoma) that has not spread to distant organs - You have not received any prior treatment for this cancer - You are in good physical health (ECOG 0–1) - Your organ function (kidney, liver, blood) meets minimum requirements - You are willing to use contraception during the study **You may NOT be eligible if...** - You have another active cancer that required treatment in the past 5 years - You have received prior systemic treatment for this cancer - You have an active infection requiring treatment - You have had pneumonia requiring steroids - You are pregnant or breastfeeding - You have serious autoimmune disease 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

IV infusion

DRUGS-1

Oral tablets

DRUGOxaliplatin

IV infusion

DRUGNab paclitaxel

IV infusion

RADIATIONRadiation

TOMO/VMAT


Locations(3)

Wuhan Tongji Hospital

Wuhan, Hubei, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT05687357


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