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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Digestive System Diseases; Neoplasms; Neoplasms by Site; Stomach Neoplasms; Digestive System Neoplasms; Stomach Diseases
• Intervention / Treatment: Procedure: Surgery; Drug: Camrelizumab; Drug: SOX

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • The Second Affiliated Hospital of Fujian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab+SOX; The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).	Procedure: Surgery; Surgery; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): March 30, 2022
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: gastric cancer; neoadjuvant chemoimmunotherapy; neoadjuvant immunotherapy
• Additional Relevant MeSH Terms: Neoplasms; Stomach Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Stomach Diseases; Neoplasms by Site
• Other Study ID Numbers: NEO-GASTRIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No