search
Back to results

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

Primary Purpose

Stomach Neoplasms, Digestive System Neoplasms, Neoplasms

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
SOX
Surgery
Sponsored by
The Second Affiliated Hospital of Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring gastric cancer, neoadjuvant chemoimmunotherapy, neoadjuvant immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age older than 18 years of age; Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma; Without prior systematic therapy; The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1; With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS; Life expectancy longer than 12 months; Adequate function of blood, heart, liver, kidney and thyroid. Exclusion Criteria: History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation; Unresectable tumor evaluated by investigator; Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, (3)myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention; With tumors in other sites; History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included; Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin; With any mental illness; Pregnant or lactating women.

Sites / Locations

  • The Second Affiliated Hospital of Fujian Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab+SOX

Arm Description

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

Outcomes

Primary Outcome Measures

Pathologic complete response (pCR) rate
The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR)

Secondary Outcome Measures

R0 resection rate
Overall response rate(ORR)
Disease control rate(DCR)
Major pathological response (MPR)
The AJCC TRG system was used in this study to determine the effects of treatment.
Adverse events (AE) rate
Event-free survival(EFS)
Overall survival(OS)

Full Information

First Posted
October 24, 2022
Last Updated
September 26, 2023
Sponsor
The Second Affiliated Hospital of Fujian Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05602935
Brief Title
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
Official Title
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Stomach Diseases, Neoplasms by Site
Keywords
gastric cancer, neoadjuvant chemoimmunotherapy, neoadjuvant immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab+SOX
Arm Type
Experimental
Arm Description
The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
200mg, intravenously, d1
Intervention Type
Drug
Intervention Name(s)
SOX
Intervention Description
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
Pathologic complete response (pCR) rate
Description
The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR)
Time Frame
2-4 months
Secondary Outcome Measure Information:
Title
R0 resection rate
Time Frame
2-4 months
Title
Overall response rate(ORR)
Time Frame
2-4 months
Title
Disease control rate(DCR)
Time Frame
2-4 months
Title
Major pathological response (MPR)
Description
The AJCC TRG system was used in this study to determine the effects of treatment.
Time Frame
2-4 months
Title
Adverse events (AE) rate
Time Frame
3 years
Title
Event-free survival(EFS)
Time Frame
3 years
Title
Overall survival(OS)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 18 years of age; Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma; Without prior systematic therapy; The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1; With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS; Life expectancy longer than 12 months; Adequate function of blood, heart, liver, kidney and thyroid. Exclusion Criteria: History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation; Unresectable tumor evaluated by investigator; Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, (3)myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention; With tumors in other sites; History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included; Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin; With any mental illness; Pregnant or lactating women.
Facility Information:
Facility Name
The Second Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs