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Trial Title:
Clinical Study of Camrelizumab, Apatinib Mesylate and Nab-paclitaxel Combined With Oxplatin and S-1 in the Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Genotypes
NCT ID:
NCT05524974
Condition:
Locally Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Oxaliplatin
Apatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.
Arm group label:
Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin for Injection 135mg/m2 /per day，ivgtt，in day1. Given once every 3 weeks.
Arm group label:
Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
Arm group label:
Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
Arm group label:
Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes
Arm group label:
Oxplatin and S-1 for Classic Genotypes
Arm group label:
Oxplatin and S-1 for Immune Genotypes
Arm group label:
Oxplatin and S-1 for Mesenchymal Genotypes
Arm group label:
Oxplatin and S-1 for Metabolic Genotypes
Intervention type:
Drug
Intervention name:
S1
Description:
S-1 was calculated according to body surface area , P.O., bid, d1-d14. And the dosage
according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2,
60mg every time
Arm group label:
Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
Arm group label:
Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
Arm group label:
Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes
Arm group label:
Oxplatin and S-1 for Classic Genotypes
Arm group label:
Oxplatin and S-1 for Immune Genotypes
Arm group label:
Oxplatin and S-1 for Mesenchymal Genotypes
Arm group label:
Oxplatin and S-1 for Metabolic Genotypes
Intervention type:
Drug
Intervention name:
Apatinib Mesylate
Description:
Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday.
Arm group label:
Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
nab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260
mg/m2 in day 1 and day 8.
Arm group label:
Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes
Summary:
To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel
combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric
cancer with different genotypes
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age from 18 to 75 years, all sex；
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by histology or cytology；
3. CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of
gastric cancer staging as cT2-4a and/or N+ and M0 before operation.；
4. measurable lesions at least should be detected by CT/MRI examination in accordance
with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter of
lymph node≥15mm，scan slice thickness 5mm）;
5. ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores;
6. the expected survival time is more than 12 weeks;
7. the main organ function is normal, which should meet the following criteria:
（1）(1)blood routine examination standards should be met（no blood transfusion within
14 days）
1. HB≥100g/L，
2. WBC≥3×109/L
3. ANC≥1.5×109/L，
4. PLT≥100×109/L； （2）biochemical examination shall comply with the following
criteria：
1. BIL <1.5normal upper limit（ULN），
2. ALT和AST<2.5ULN，GPT≤1.5×ULN；
3. serum Cr≤1ULN，creatinine clearance rate>60ml/min（Cockcroft-Gault formula）
8. women of childbearing age must have a pregnancy test in 7 days before entering the
group (in serum), and the results were negative, and willing to use appropriate
contraception during the study period and the last 8 weeks after giving drug; men
should have the surgical sterilization, or adopt the appropriate contraceptive
methods during the test and the last 8 weeks after giving drug.；
9. No other clinical studies were conducted before and during the treatment；
participants is willing to participate in this study, sign the informed consent,
have good compliance, cooperate with follow-up.
Exclusion Criteria:
1. Previous history of chemotherapy, radiotherapy, targeted drug therapy or
immunotherapy
2. Patients with contraindications for surgical treatment and chemotherapy or whose
physical condition and organ function do not allow for major abdominal surgery；
3. patients with metastasis；
4. Having any active autoimmune diseases or a history of autoimmune diseases (such as
interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation,
vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but
not limited to these diseases or syndromes); Patients with vitiligo or cured
childhood asthma/allergies who did not need any intervention in adulthood were
excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid
replacement hormone; Type 1 diabetes with stable doses of insulin；
5. A history of immunodeficiency, including HIV testing positive, or other acquired or
congenital immunodeficiency disorders, or a history of organ transplantation and
allogeneic bone marrow transplantation；
6. Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental
disease; Jaundice or obstruction of the digestive tract with severe infection；
7. pregnant or lactating women；
8. The blood pressure of patients with hypertension cannot be reduced to the normal
range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure
>90 mmHg)；
9. With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted
between male > 450 ms, women > 470 ms) and cardiac insufficiency；
10. Patients have a clear tendency with gastrointestinal bleeding, including the
following situation: local active ulcerative lesions, and fecal occult blood (+ +);
with melena and hematemesis history in 2 months; and patients with fecal occult
blood (+) and coagulation dysfunction (INR(international normalized ratio)>1.5,
APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;；
11. Subjects have failed to control good cardiovascular clinical symptoms or disease,
including but not limited to: such as: (1) the NYHA class II heart failure or above
(2) unstable angina pectoris (3) MI occurred within 1 year (4) have clinical
significance of supraventricular or ventricular arrhythmias without clinical
intervention on or after clinical intervention is still poorly controlled；
12. History of interstitial lung disease (except radiation pneumonia without hormone
therapy), and history of non-infectious pneumonia；
13. Patients are positive of urine protein (urine protein detection 2+ or above, or 24
hours urine protein quantitative >1.0g)；
14. A person who has previously been allergic to any component of the drug in this
study； The researchers consider those who were not suitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Start date:
September 1, 2022
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Fujian Medical University
Agency class:
Other
Source:
Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524974
