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Trial Title:
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
NCT ID:
NCT05602935
Condition:
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms
Digestive System Diseases
Stomach Diseases
Neoplasms by Site
Conditions: Official terms:
Neoplasms
Stomach Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Conditions: Keywords:
gastric cancer
neoadjuvant chemoimmunotherapy
neoadjuvant immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
200mg, intravenously, d1
Arm group label:
Camrelizumab+SOX
Intervention type:
Drug
Intervention name:
SOX
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)
Arm group label:
Camrelizumab+SOX
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Surgery
Arm group label:
Camrelizumab+SOX
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Start date:
September 16, 2020
Completion date:
December 30, 2026
Lead sponsor:
Agency:
The Second Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
The Second Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05602935
