A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab

Advanced Gastric Adenocarcinoma Clinical Trial

Official title:

A Phase II Clinical Study of the New Adjuvant Treatment of HER-2 Positive Resectable Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583383
• Other study ID #: SHR-1210-GC-002
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2022
• Source: Henan Cancer Hospital
• Contact: LiuYing LiuYing, Doctor
• Phone: 13783604602
• Email: yaya7207[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Gastric Adenocarcinoma

Intervention

Drug:
• camrelizumab
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.

Locations

Country	Name	City	State
China	Henan Tumor Hospital	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response rate(pCR)	Refers to the absence of tumor cell residue in the primary tumor.	up to 2 years
Secondary	Disease-free survival	Defined as postoperative disease-free subjects, starting from the time of postoperative baseline imaging evaluation to the time of disease recurrence or death.	up to 2 years
Secondary	Overall survival	defined as the time from the first medication to the death of a subject from any cause after enrollment. For the subjects who survived at the last contact, their total survival will be deleted on the last contact day.	up to 2 years
Secondary	Major pathological response rate	The survival tumor cells in the resected specimen were =10%.	up to 2 years
Secondary	R0 resection rate	There was no macroscopic tumor at the surgical margin, and the tumor cells at the surgical margin were negative within 1mm under microscope.	up to 2 years