Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positiv… (NCT05111444) | Clinical Trial Compass
UnknownPhase 2
Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
China65 participantsStarted 2021-12-31
Plain-language summary
This study is designed to evaluate the efficacy and safety of Camrelizumab plus pyrotinib in combination with chemotherapy in patients with HER2-positive gastric cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older.
✓. Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma.
✓. Patients have not received systemic treatment in the past but had disease progression more than 6 months after receiving neoadjuvant therapy or the last of adjuvant therapy could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months.
✓. HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with fluorescent in-situ hybridization (FISH+ is defined as HER2:CEP17 ratio≥2.0), as assessed by central review on primary or metastatic tumor.
✓. ECOG performance status 0-1.
✓. At least one measurable lesion exists as defined by RECIST 1.1 .
✓. Life expectancy of more than 12 weeks.
Exclusion criteria
✕. Hypersensitivity to Camrelizumab, pyrotinib and study chemotherapy agents and/or to any components.
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, Cluster of Differentiation 137 \[CD137\]).
✕. Has an active autoimmune disease that has required systemic treatment in past 2 years.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: [ Time Frame: Up to approximately 2 years ]