NCT03878472

Neoadjuvant Immunotherapy for Resectable Gastric Cancer

A Phase II Clinical Study of Neoadjuvant Therapy for Resectable Locally Advanced Gastric Cancer with PD-1 Antibody or in Combination with Apatinib ± S1±Oxaliplatin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

1. Target population: patients with resectable locally advanced gastric cancer (cT3-4bN+M0). 2. Primary objective: (1) To evaluate the pathological remission rate (PRR) of PD-1 antibody monotherapy or in combination with anti-angiogenesis VEGFR2-TKI apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer. (2) To evaluate the relationship between tumor pathological remission and biomarkers related to immunotherapy. 3\. Secondary objectives: 1. To evaluate the imaging objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of PD-1 antibody alone or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant therapy for locally advanced gastric cancer. 2. To evaluate the safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer. Trial design: This is a monocenter, open, single arm, phase II study to evaluate the efficacy and safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant treatment of resectable locally advanced gastric cancer.

Detailed description

Several important clinical trials including MAGIC, FLOT4, POET, RTOG 9904 and TOPGEAR have identified the efficacy and safety of neoadjuvant treatment in treating locally advanced GEJ cancer or gastric cancer. patients with resectable locally advanced gastric cancer will receive neoadjuvant treatment of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin. The investigators will shut down the study in advance, if situations below happens: 1) 1 treatment related death, \>3 disease progression or \>2 hyper-progressive disease happen during the first stage; 2) 2 treatment related death, \>6 disease progression or \>4 hyper-progressive disease happen during the whole study. Patients with abnormal autoimmune status, unfavorable body function, factors impeding drug taking, absorption and metabolism will be excluded. Study participants with disease progression or severe/ intolerant toxicity during treatment will withdraw the study. Hyper-progressive disease is defined as 1) progression 2) more than doubled growth rate 3) tumor volume increase \>50% in 2 months after initialing the treatment.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	SHR1210	The patients will receive at least two cycles of SHR-1210 (200 mg, invdrip d1) every two weeks and be accessed for operational suitability every two cycles.
DRUG	Apatinib	The patients will received apatinib (250mg po qd) until 10 ± 2 days before surgery.
DRUG	S1	The patients will received S1 (50 mg/m2, po, bid, d1-d10) every two weeks and be accessed for operational suitability every two cycles.
DRUG	Oxaliplatin	The patients will receive at least two cycles of oxaliplatin (85 mg/m2 d1) every two weeks and be accessed for operational suitability every two cycles.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-06-01
• Completion: 2024-05-31
• First posted: 2019-03-18
• Last updated: 2024-12-16

Locations

1 site across 1 country: China