Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment

Официальное название

Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study

Обзор

to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.

Подробное описание

This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.

Вмешательства

• Препарат Capecitabine plus toripalimab
  Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks

Первичные конечные точки

• progression-free survival(PFS) [Срок оценки: up to 24 month]

Вторичные конечные точки (5)

• overall survival(OS) [Срок оценки: up to 24 month]
• Objective Response Rate(ORR) [Срок оценки: up to 24 month]
• Disease Control Rate (DCR) [Срок оценки: up to 24 month]
• Duration of Response (DoR) [Срок оценки: up to 24 month]
• Adverse Events (AEs) [Срок оценки: up to 24 month]

Критерии участия

Критерии включения

• Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
• Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
• Age ≥18 years and ≤65 years
• WBC≥4×10\^9/L, platelet ≥ 100×10\^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
• With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
• With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
• ECOG score is 0-1
• At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
• Life expectancy is at least 12 weeks
• Patients sign informed consent forms

Критерии исключения

• History of severe anaphylaxis to any component of capecitabine or toripalimab
• Active or untreated central nervous system metastases
• Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
• Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
• Patients with poorly controlled or symptomatic hypercalcemia
• Pregnancy or lactation
• Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.
• Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
• History of autoimmune diseases
• Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.
• Receive any active vaccine within 4 weeks prior to enrollment
• Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
• Active pneumonia
• Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
• Presence of severe neurological or psychiatric disorders, including dementia and seizures.
• Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
• Major cardiovascular diseases

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05484375 · IIT-2022-017(FL5)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗