A phase II clinical trial examining trastuzumab biosimilar (CT-P6) and chemotherapy (oxaliplatin +S-1 or oxaliplatin +Capecitabine) for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy

JRCT ID: jRCTs071190007

Registered date:17/05/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 20/06/2019
• Target sample size: 68
• Study type: Interventional

Intervention(s)

A
A course of treatment lasts 21 days, and treatment will be continued until any of the Criteria for Discontinuation of the Protocol Treatment are met. On day 1, trastuzumab 8 mg/kg (from the second dose to 6 mg/kg) and oxaliplatin 130 mg/m2 will be administered intravenously. In accordance with body surface area, S-1 40-60 mg will be given orally twice a day, once after breakfast and once after dinner, for 14 consecutive days (starting at dinner on day 1 and given until breakfast on day 15), followed by a 7-day rest period.

B
A course of treatment lasts 21 days, and treatment will be continued until any of the Criteria for Discontinuation of the Protocol Treatment are met. On day 1, trastuzumab 8 mg/kg (from the second dose to 6 mg/kg) and oxaliplatin 130 mg/m2 will be administered intravenously. In accordance with body surface area, capecitabine 1200-2100 mg will be given orally twice a day, once after breakfast and once after dinner, for 14 consecutive days (starting at dinner on day 1 and given until breakfast on day 15), followed by a 7-day rest period.

Outcome(s)

• Primary Outcome: Response Rate
• Secondary Outcome: Safety profile, progression-free survival (PFS), overall survival (OS), time-to-treatment failure (TTF), Duration of treatment, time to failure of strategy (TFS), dose intensity, comparison between treatment arms (Response proportion, Safety profile, PFS, OS, TTF, Duration of treatment, TFS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)The individual consents in writing to receipt of the protocol treatment
2)A lead investigator deems that the patient can be treated with the protocol (the patient is suitable for enrollment)
3)The cancer is histopathologically confirmed (via resected surgical specimens biopsied tissue) to be a common type of gastric cancer (adenocarcinoma)
4)Up to 28 days prior to enrollment, contrast-enhanced CT scans of the trunk (chest,upper abdomen,and pelvis) confirm that 1 or more target lesions is present according to RECIST v1.1
5)The primary tumor or a metastatic focus is determined to be HER2-positive
6)The patient has not previously received chemotherapy, immunotherapy, or radiation therapy (except for local irradiation of bone metastases)
7)When a patient has advanced/recurrent gastric cancer not amenable to curative surgery
8)When a patient undergoes surgery for gastric cancer in the form of extensive surgery, standard surgery, or some other procedure, trial participation will be at least 2 weeks afterwards when postoperative complications have abated
9)The patient's age upon enrollment is over 20 years
10)The patient has a PS of 0 or 1 on the ECOG Scale
11)The patient is readily able to take medication orally
12)The patient is fully expected to survive for 3 months or longer from the day of enrollment
13)The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
i)WBC count<=12,000/mm3
ii)Neutrophil count>=1,500/mm3
iii)Platelet count>=100,000/mm3
iv)Hemoglobin>=8.0g/dL
v)Total bilirubin<=1.5mg/dL
vi) AST,ALT<=100IU/L
*200 IU/L or lower when liver metastasis is noted
vii)Albumin>=2.5g/dL
viii)Serum creatinine<=1.5mg/dL
ix)Creatinine clearance>=50mL/min1)The individual consents in writing to receipt of the protocol treatment
14) Left ventricular ejection fraction (LVEF) measured by echocardiography or cardiac scan multi-gating method (MUGA) within 14 days before registration is 50% or more

Exclude criteria

1)A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment
2)The patient has severe drug hypersensitivity(particularly to platinum analogs, 5-FU, or S-1)
3)The patient has peripheral neuropathy affecting the sensory nerves(Grade 1 or worse)
4)The patient has an active infection
5)The patient has poorly controlled hypertension
6)The patient has poorly controlled diabetes(patients with controlled diabetes who are receiving insulin treatment are eligible for enrollment)
7) Significant electrocardiogram abnormality is recognized by 12 lead electrocardiogram within 14 days before registration, or the patient has heart disease that may pose a problem
8)The patient has severe pulmonary disease
9)he patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction
10)The patient has active gastrointestinal tract bleeding requiring repeated transfusions
11)The patient is receiving phenytoin, warfarin potassium,or flucytosine
12)The patient has moderate or more severe fluid accumulation in body cavities,such as pleural effusions and ascites,that continually requires treatment such as drainage
13)The patient has brain metastasis or clinical features suggesting brain metastasis
14)The patient has extensive bone metastasis(as determined by the patient's primary physician)
15)The patient has watery diarrhea(watery stool)(Grade 2 or worse)
16)The patient has active multiple cancers
17)The patient has a history of receiving platinum-based antineoplastic agents(e.g. oxaliplatin and cisplatin)
18)A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner
19)The patient tests positive for HBsAg or antibodies to HCV(Date of testing required)
20)A patient who is deemed to need antiviral therapyb(as of enrollment) for HBV-related hepatitis
21)A lead investigator or the patient's primary physician otherwise deems that participation in this trial is not appropriate for the patient

Related Information

• Primary Sponsor: Oki Eiji
• Source(s) of Monetary Support: Nippon Kayaku Co.,Ltd.