Overview
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 Herceptin as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer.
Description
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 Herceptin as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic gastric cancer. The HER2-expression is defined as: the HER2 IHC 3+ or 2+, or 1+.
Eligibility
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- Age:18-70 years（including 18 and 70）.
- 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+.
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.
