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

Advanced Gastric Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The treatment of advanced gastric cancer has been a significant global health problem. With surgery still the backbone, various clinical trials have shown the benefit of perioperative treatment to gastric cancer patients.

The report of transcatheter arterial chemoembolization (TACE) treatment in gastric cancer is relatively limited, though different case reports have showed its efficacy and safety in advanced gastric cancer. With transarterial infusion chemotherapy, TACE increases the local concentration of chemotherapeutic agents and reduces adverse reaction. With embolization, TACE blocks the blood supply and causes the necrosis of tumors, in this way exposing tumor antigen and promoting tumor immunity. The combination of TACE and PD-1 antibody is expected to further boost tumor immunity.

Meanwhile, Noman et.al. reported hypoxia could upregulate PD-L1 by activating HIF-1alpha. So, embolism may lead to immune evasion of tumors by upregulating PD-L1, but on the other side generate targets for PD-1/PD-L1 therapies.

Based on those knowledges, we designed this 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 PFS (progression-free survival) of the patients enrolled in this study. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Gastric Cancer

• NCT number: NCT04799548
• Study type: Interventional
• Source: Shanghai Zhongshan Hospital
• Contact: Zhaoqing Tang, MD, phD
• Phone: 86-13817125778
• Email: tang.zhaoqing@zs-hospital.sh.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: December 30, 2021
• Completion date: January 2026