Camrelizumab Combined With SOX and/or Apatinib for Locally Advanced Gastric Cancer

Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Study ID
NCT04792515
Phase
PHASE2
Status
Unknown

Conditions

  • Locally Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab combined with SOX/ or apatinib — DRUG
    Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed. Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery. Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed. Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours. Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14. The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing.

Study Details

This study was designed to evaluate the efficacy and safety of camrelizumab in combination with SOX and/or apatinib in the treatment of locally advanced gastric cancer or gastroesophageal junction adenocarcinoma.The primary endpoint was pathologic complete response (PCR).In addition, secondary efficacy endpoints include R0 resection rate, objective response rate (ORR), and 1-year progression-free survival rate (PFSR) . They were set to demonstrate the therapeutic benefit of camrelizumab combined with SOX in patients 。

Key Dates

Start date
Jan 1, 2021
Status verified
Jan 2021
Primary completion
Jun 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group
    Patients were treated with camrelizumab combined with SOX/ or apatinib

Primary Outcome Measure

pathologic complete response (PCR) [ Time Frame: 6month ]

Central Contacts