Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Gastric Neoplasms
- Sponsor
- Fudan University
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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-
- •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.
- •Has a known history of Human Immunodeficiency Virus (HIV) or active hepatitis B and C virus infection.
- •Has had major surgery within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment.
- •Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- •Evidence or history of coagulation disorders such as a grade ≥ 3 (CTC-AE) bleeding event.
- •Known history of psychotropic substance abuse or drug use.
Arms & Interventions
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
Intervention: Camrelizumab
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
Intervention: Pyrotinib
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
Intervention: Capecitabine
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
Intervention: Oxaliplatin
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
Intervention: Paclitaxel
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
Intervention: S-1
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: [ Time Frame: Up to approximately 2 years ]
Objective response rate assessed at 18 weeks after enrollment，that is about 6 cycles of treatment
Secondary Outcomes
- Overall Survival (OS)([ Time Frame: Up to approximately 2 years ])
- Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR([ Time Frame: Up to approximately 2 years ])