Neoadjuvant Immunotherapy for Resectable Gastric Cancer

Sponsor
Qilu Hospital of Shandong University
Study ID
NCT03878472
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR1210 — DRUG
    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.
  • Apatinib — DRUG
    The patients will received apatinib (250mg po qd) until 10 ± 2 days before surgery.
  • S1 — DRUG
    The patients will received S1 (50 mg/m2, po, bid, d1-d10) every two weeks and be accessed for operational suitability every two cycles.
  • Oxaliplatin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2019
Status verified
May 2021
Primary completion
Jun 1, 2022
Completion
May 31, 2024

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant immunotherapy with PD-1
  • Experimental: Neoadjuvant immunotherapy with PD-1+apatinib
  • Experimental: Neoadjuvant immunotherapy with PD-1+apatinib+S1
  • Experimental: Neoadjuvant immunotherapy with PD-1+apatinib+S1+Oxaliplatin

Primary Outcome Measure

Pathological remission rate (PRR) rate 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. [ Time Frame: 5 months after the last subject participating in ]

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