A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

Korábbi kezelés

• Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption
• Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment

Más betegség

• Past or current interstitial lung disease, or severely impaired lung function

Egyéb

• Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
• Peripheral neuropathy > Grade 1
• Tumor lesions with a tendency to bleed
• Bone metastases with a risk of paraplegia
• Pregnant or breastfeeding women

• Voluntarily consent to participate in the study and sign the informed consent form
• Expected survival period >12 weeks
• ECOG Performance Status 0 or 1
• Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma
• No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy
• HER2-high expression
• At least one assessable lesion according to RECIST v1.1 criteria
• Adequate organ function
• Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.
• Able to understand the study requirements and willing to comply with the study and follow-up procedures