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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05602935
• Other study ID #: NEO-GASTRIC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 16, 2020
• Est. completion date: December 30, 2026

Study information

• Verified date: November 2022
• Source: The Second Affiliated Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: December 30, 2026
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Camrelizumab
200mg, intravenously, d1
• 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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2-4 months
Secondary	R0 resection rate		2-4 months
Secondary	Overall response rate(ORR)		2-4 months
Secondary	Disease control rate(DCR)		2-4 months
Secondary	Major pathological response (MPR)	The AJCC TRG system was used in this study to determine the effects of treatment.	2-4 months
Secondary	Adverse events (AE) rate		3 years
Secondary	Event-free survival(EFS)		3 years
Secondary	Overall survival(OS)		5 years