Clinical trial NCT05602935: Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stomach Neoplasms
Digestive System Neoplasms
Neoplasms
Digestive System Diseases
Stomach Diseases
Neoplasms by Site
Keywords: gastric cancer
neoadjuvant chemoimmunotherapy
neoadjuvant immunotherapy
Lead sponsor: The Second Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pathologic complete response (pCR) rate
timeFrame: 2-4 months
Secondary outcomes:
measure: R0 resection rate
timeFrame: 2-4 months
measure: Overall response rate(ORR)
timeFrame: 2-4 months
measure: Disease control rate(DCR)
timeFrame: 2-4 months
measure: Major pathological response (MPR)
timeFrame: 2-4 months
measure: Adverse events (AE) rate
timeFrame: 3 years
measure: Event-free survival(EFS)
timeFrame: 3 years
measure: Overall survival(OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References: