Gastric Cancer
Conditions
Brief summary
This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
Interventions
DRUGRC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
DRUGTrastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
DRUGToripalimab
3.0 mg/kg intravenous infusion every 2 weeks
DRUGOxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
DRUGCapecitabine（1000mg/m2）
1000mg/m2 per os Q3W
DRUGRC48-ADC（2.0mg/kg）
2.0 mg/kg intravenous infusion every 2 weeks
DRUGCapecitabine（750mg/m2）
750mg/m2 per os Q3W
DRUGOxaliplatin（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Voluntary agreement to provide written informed consent. * Age:18-75 years（including 18 and 75）. * Predicted survival ≥ 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate organ function. * All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma. * Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; * HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+ or IHC0.
Exclusion criteria
* Active central nervous system (CNS) metastases. * Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection. * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal. * Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components. * Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to approximately 2 years | The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety(adverse event) | Up to approximately 2 years | to evaluate safety including adverse event rate and adverse event grade. |
| Progression-free survival (PFS), evaluated by the investigator | Up to approximately 2 years | Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard. |
| Overall survival (OS) | Up to approximately 2 years | Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject. |
| Duration of response (DOR) | Up to approximately 2 years | DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death |
| Disease Control Rate(DCR) | Up to approximately 2 years | DCR is the proportion of subjects with optimal overall response to achieve objective remission or stable disease over the course of the study |
Countries
China
Outcome results
None listed