A Phase II Study of Neoadjuvant Transcatheter Arterial Chemoembolization（TACE）Plus PD-1 Antibody (Tislelizumab) in the Locally Advanced Stomach Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Transcatheter Arterial Chemoembolization
- Conditions
- Advanced Gastric Cancer
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- pathologic complete response (pCR) rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 18 to 75 years old;
- •KPS score \>=80;
- •Gastric adenocarcinoma diagnosed pathologically;
- •According to endoscopic ultrasonography/enhanced CT/MRI/PET-CT examination and laparoscopic exploration, clinical staging is determined to be cT3/4aN+M0 (according to AJCC TNM 8th edition);
- •According to the RECIST1.1 standard, there is at least one evaluable lesion in the abdominal CT/MRI;
- •The surgeons participating in this study judged the lesion to be resectable;
- •Physical condition allows the surgery;
- •The blood routine and biochemical indexes of the subjects met standards within 7 days before enrollment:
- •There are no serious concomitant diseases that make the survival time \<5 years;
- •Female subjects with fertility are not allowed to get pregnant or breastfeeding;
Exclusion Criteria
- •There are any signs of distant metastasis or local unresectable factors;
- •Those who are allergic to contrast agents;
- •Those who have received cytotoxic chemotherapy, radiotherapy, immunotherapy or radical surgery for the treatment of this gastric cancer, except for corticosteroids;
- •Patients who have active autoimmune diseases or have a history of autoimmune diseases but may relapse;
- •Any active malignant tumors within 2 years, except the specific cancers under study in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer);
- •There is uncontrollable pleural effusion, pericardial effusion or ascites that requires frequent drainage within 14 days before enrollment;
- •Patients with gastrointestinal bleeding within two weeks prior to enrollment, or those with high bleeding risk as judged by the investigators;
- •Gastrointestinal perforation and/or fistula occurred within 6 months before enrollment;
- •Upper gastrointestinal obstruction or abnormal physiological function or suffering from malabsorption syndrome, which may affect the absorption of drugs;
- •Weight loss \>=20% within 2 months before enrollment;
Arms & Interventions
neoadjuvant TACE plus Tislelizumab
Intervention: Transcatheter Arterial Chemoembolization
neoadjuvant TACE plus Tislelizumab
Intervention: Tislelizumab
Outcomes
Primary Outcomes
pathologic complete response (pCR) rate
Time Frame: 1 months
Secondary Outcomes
- pathologic response rate (pRR)(1 months)
- progression-free survival (PFS)(3 years)
- objective Response Rate (ORR)(1 months)
- overall survival (OS)(3 years)