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Trial Title:
A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab
NCT ID:
NCT05583383
Condition:
Advanced Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
camrelizumab
Description:
camrelizumab was administered intravenously at a fixed dose of 200 mg, on the first day,
once every 3 weeks, with a cycle of 3 weeks. Infusion for 30 min each time (no less than
20 min and no more than 60min); SOX: Oxaliplatin: 130 mg/m2, administered intravenously,
on the first day, once every three weeks, and every three weeks is a cycle; S-1:
according to BSA (< <1.25 40 mg；; 1.25-1.5 50 mg； > >1.5 60 mg), oral administration,
d1-d14 twice a day, 3 weeks as a cycle; Trastuzumab was administered intravenously, with
an initial loading dose of 8 mg/kg and a subsequent dose of 6 mg/kg, with a cycle of 3
weeks.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Summary:
A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With
Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab
Detailed description:
To observe the efficacy, safety, postoperative pathological remission rate and survival
benefit of patients with HER-2 positive locally advanced adenocarcinoma of stomach and
gastroesophageal junction treated with camrelizumab+SOX combined with trastuzumab or not.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1) Age 18-75 years old; Male or female; 2) Histopathological examination of
gastroscopy biopsy confirmed adenocarcinoma of stomach and gastroesophageal
junction; 3) Imaging (CT/MRI) and ultrasonic gastroscopy confirmed that: cT≥T2
and/or regional lymph node positive (N+); 4)HER-2 positive is the test result
of IHC3+ or IHC2+/FISH+, and HER-2 test score standard refers to her-2 test
guide for gastric cancer; 5)ECOG score: 0~1; 6) The expected survival time is ≥
12 weeks; 7) The main organ functions meet the following criteria within 7 days
before treatment:
1. Blood routine examination standard (without blood transfusion within 14 days):
Hb ≥ 90g/l; The absolute value of neutrophils (ANC) ≥ 1.5× 109/L; Platelet
(PLT) ≥ 80× 109/L;
2. Biochemical examination shall meet the following standards:
Total bilirubin (TBIL)≤1.5 times the upper limit of normal value (ULN); Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN; Serum creatinine
(Cr)≤1.5 ULN or creatinine clearance rate (CCR) ≥ 60ml/min; (3) Doppler ultrasound
evaluation: Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value
(50%).
8) Women of childbearing age should agree to take contraceptive measures (such as
intrauterine device, contraceptive pill or condom) during the study period and
within 6 months after the end of the study; Serum or urine pregnancy test was
negative within 7 days before the study was enrolled in the group, and it must be a
non-lactating patient; Men should agree to patients who must use contraception
during the study period and within 6 months after the end of the study period.
9) Patients volunteered to participate in this study and signed an informed consent
form;
Exclusion Criteria:
-
1) have had or are currently suffering from other malignant tumors within 5 years,
except cured cervical carcinoma in situ, non-melanoma skin cancer and
superficial bladder tumor [Ta (non-invasive tumor), Tis (cancer in situ) and T1
(tumor infiltrating basement membrane)]; 2) Patients with distant metastasis
and unable to undergo surgical resection; 3) Have a history of mental illness,
or abuse of psychotropic drugs; 4) Subjects with diseases requiring systemic
treatment with glucocorticoid (> 10 mg prednisone equivalent dose per day) or
other immunosuppressive drugs within 14 days before the start of study
treatment. In the absence of active autoimmune diseases, it is allowed to use
inhaled or topical steroids > 10 mg daily prednisone equivalent dose and
adrenal replacement steroid dose; 5) Those who have received any anti-tumor
treatment in the past; 6) Participants who receive live/attenuated vaccines
within 30 days; 7) Allergic reactions and adverse drug reactions:
1. History of allergy to the ingredients of the study drug;
2. Contraindications of any study drug (oxaliplatin or S-1) in chemotherapy
regimen.
8) Patients with any severe and/or uncontrollable diseases, including:
1. Patients with hypertension who can't get good control after antihypertensive
drug treatment (systolic blood pressure ≥180 mmHg, diastolic blood pressure
≥100 mmHg);
2. Suffering from grade I or above myocardial ischemia or myocardial infarction,
arrhythmia (including QTc≥480 ms) and grade 2 or above congestive heart failure
(new york Heart Association (NYHA) classification);
3. Severe or uncontrolled disease or active infection (≥ CTCAE level 2 infection),
which the researcher believes will increase the risks related to research
participation, administration of research drugs or affect the ability of
subjects to receive research drugs;
4. Renal failure requires hemodialysis or peritoneal dialysis;
5. those who have a history of immunodeficiency diseases, including HIV-positive
or other acquired and congenital immunodeficiency diseases, or have a history
of organ transplantation; 9) Patients with a large number of ascites or poor
ascites control; 10) preparing for or receiving allogeneic organ or allogeneic
bone marrow transplantation, including liver transplantation; 11) Patients with
brain metastasis; 12) Patients who are not suitable to participate according to
the researcher's judgment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Tumor Hospital
Address:
City:
Henan
Country:
China
Status:
Recruiting
Contact:
Last name:
LiuYing LiuYing, Doctor
Phone:
13783604602
Email:
yaya7207@126.com
Start date:
March 31, 2022
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05583383
