RecruitingPhase 2NCT04799548

A Phase II Study of TACE Plus PD-1 Antibody in the Locally Advanced Stomach Adenocarcinoma

A Phase II Study of Neoadjuvant Transcatheter Arterial Chemoembolization（TACE）Plus PD-1 Antibody (Tislelizumab) in the Locally Advanced Stomach Adenocarcinoma

Sponsor

Shanghai Zhongshan Hospital

Enrollment

71 participants

Start Date

Dec 30, 2021

Study Type

INTERVENTIONAL

Conditions

Advanced Gastric Cancer

Summary

This study is a phase II, prospective, single-center, single-arm trial to evaluate the efficacy and safety of the combination of neoadjuvant transcatheter arterial chemoembolization (TACE) and PD-1 antibody Tislelizumab in the locally advanced stomach adenocarcinoma. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACE plus Tislelizumab. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a liver-directed procedure (TACE — injecting chemotherapy directly into tumor blood vessels) with an immunotherapy drug (a PD-1 antibody) can shrink locally advanced stomach cancer before surgery, potentially making more patients eligible for curative surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stomach adenocarcinoma (confirmed by biopsy) - Your cancer is locally advanced but has not spread to distant organs (stage cT3/4aN+M0) - You are in good general health (KPS score ≥ 80) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have severe heart, liver, or kidney disease - 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

DRUGTranscatheter Arterial Chemoembolization

Patients will sequentially receive one cycle TACE (3 weeks), one cycle SOX regimen (3 weeks), one cycle TACE (3 weeks) and one cycle SOX (3 weeks) regimen, a total of 12-week neoadjuvant therapy. TACE cycle: Day 1: trans-femorally performed with infusion of oxaliplatin (85 mg/m2) into tumor blood vessels. Then, Embosphere® Microspheres (300-500 μm) will be injected for embolism. Day 1-14: Oral Tegafur Gimeracil Oteracil Potassium Capsule 40-60 mg bid. SOX cycle: Day 1: Oxaliplatin 130mg/m2 intravenous. Day 1-14: Oral Tegafur gimeracil oteracil potassium capsule 40-60 mg bid.

DRUGTislelizumab

PD-1 antibody Tislelizumab will be administrated by 200mg, ivgtt, q3w throughout 12-week neoadjuvant treatment.

Locations(1)

ZhongShan hospital Fudan university

Shanghai, Shanghai Municipality, China

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