Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study

Sponsor
The Second Affiliated Hospital of Fujian Medical University
Study ID
NCT05602935
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Digestive System Diseases
  • Digestive System Neoplasms
  • Neoplasms
  • Neoplasms by Site
  • Stomach Diseases
  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    200mg, intravenously, d1
  • SOX — DRUG
    SOX (S-1: 40\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
  • Surgery — PROCEDURE
    Surgery

Study Details

This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.

Key Dates

Start date
Sep 16, 2020
Status verified
Nov 2022
Primary completion
Mar 30, 2022
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: Camrelizumab+SOX
    The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).

Primary Outcome Measure

Pathologic complete response (pCR) rate [ Time Frame: 2-4 months ]

Related Studies