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 (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05602935

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms Digestive System Neoplasms Neoplasms Digestive System Diseases Stomach Diseases Neoplasms by Site	Drug: Camrelizumab Drug: SOX Procedure: Surgery	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Camrelizumab+SOX The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).	Drug: Camrelizumab 200mg, intravenously, d1 Drug: SOX SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle) Procedure: Surgery Surgery

Arm

Intervention/Treatment

Experimental: Camrelizumab+SOX

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

Drug: Camrelizumab

200mg, intravenously, d1

Drug: SOX

SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)

Procedure: Surgery

Surgery

Outcome Measures

Primary Outcome Measures

Pathologic complete response (pCR) rate [2-4 months]
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 [2-4 months]
Overall response rate(ORR) [2-4 months]
Disease control rate(DCR) [2-4 months]
Major pathological response (MPR) [2-4 months]
The AJCC TRG system was used in this study to determine the effects of treatment.
Adverse events (AE) rate [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18-75 years, male or female;
Histologically or cytological confirmed gastric 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 cT3-4bN0-3M0 evaluated by CT/MRI/EUS;
Life expectancy of at least 3 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.