Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

Официальное название

A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy

Обзор

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

Вмешательства

• Препарат camrelizumab
  200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
• Препарат Apatinib Mesylate
  250 mg qd
• Препарат Paclitaxel
  80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
• Препарат Irinotecan
  180 mg/m\^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.

Первичные конечные точки

• Overall Survival (OS) in PD-L1 Positive Participants. [Срок оценки: Up to 27 months]

Вторичные конечные точки (12)

• Overall Survival (OS) in All Participants. [Срок оценки: Up to 27 months]
• Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants. [Срок оценки: Up to 27 months]
• Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [Срок оценки: Up to 27 months]
• Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants [Срок оценки: Up to 27 months]
• Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [Срок оценки: Up to 27 months]
• Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants. [Срок оценки: Up to 27 months]
• Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [Срок оценки: Up to 27 months]
• Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [Срок оценки: Up to 27 months]
• The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. [Срок оценки: Up to 27 months]
• Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. [Срок оценки: Up to 27 months]
• Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline [Срок оценки: Up to 27 months]
• Serum concentration of camrelizumab [Срок оценки: Up to 27 months]

Критерии участия

Критерии включения

• Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
• Confirmed metastatic or locally advanced, unresectable disease.
• Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
• Willing to provide tumor tissue for PD-L1 biomarker analysis.
• Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
• ECOG performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• Signing the informed consent forms.
• Adequate bone marrow, liver and renal function.

Критерии исключения

• Squamous cell or undifferentiated gastric cancer.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
• Clinically significant cardiovascular and cerebrovascular diseases.
• Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
• Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
• Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
• Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
• Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Affiliated Hospital, Academy of Military Medical Sciences — Пекин

Идентификаторы

NCT: NCT04342910 · SHR-1210-III-316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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