NCT04799548

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Gastric Cancer

Interventions

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

Timeline

• Start date: 2021-12-30
• Primary completion: 2024-12-01
• Completion: 2026-01-01
• First posted: 2021-03-16
• Last updated: 2024-05-23

Locations

1 site across 1 country: China