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

Phase 2

Active, not recruiting

• Conditions: Neoplasms by Site; Stomach Neoplasms; Digestive System Neoplasms; Neoplasms; Digestive System Diseases; Stomach Diseases
• Interventions: Drug: Camrelizumab; Drug: SOX; Procedure: Surgery

• Registration Number: NCT05602935
• Lead Sponsor: The Second Affiliated Hospital of Fujian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Primary Completion: 2022-03-30
• Study First Submitted: 2022-10-24
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-02
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. Age older than 18 years of age;
2. Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma;
3. Without prior systematic therapy;
4. The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
5. With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
6. Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS;
7. Life expectancy longer than 12 months;
8. Adequate function of blood, heart, liver, kidney and thyroid.

Exclusion Criteria

1. History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
2. Unresectable tumor evaluated by investigator;
3. 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;
4. With tumors in other sites;
5. 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;
6. Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin;
7. With any mental illness;
8. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab+SOX	Camrelizumab	The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).
Camrelizumab+SOX	SOX	The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).
Camrelizumab+SOX	Surgery	The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
R0 resection rate	2-4 months
Disease control rate(DCR)	2-4 months
Event-free survival(EFS)	3 years
Overall survival(OS)	5 years
Overall response rate(ORR)	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

Trial Locations

Locations (1)

The Second Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China