Metastatic Nasopharyngeal Carcinoma

Официальное название

Penpulimab Plus Gemcitabine and Anlotinib in the Treatment of Metastatic Nasopharyngeal Cancer, A Single Arm, Open-label, Phase Ib Clinical Trial

Обзор

To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.

Вмешательства

• Препарат Penplimab Injection
  Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 week
• Препарат Antitinib Hydrochloride Capsules
  10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.
• Препарат Gemcitabine
  Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.

Первичные конечные точки

• PFS [Срок оценки: Baseline up to 2 years]

Вторичные конечные точки (8)

• Objective Response Rate（ORR） [Срок оценки: Baseline up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: Baseline up to 2 years]
• Overall survival (OS) [Срок оценки: Baseline up to 2 years]
• Time to Response (TTR) [Срок оценки: Baseline up to 2 years]
• Duration of Response (DOR) [Срок оценки: Baseline up to 2 years]
• PD-L1 expression [Срок оценки: Tumor tissue samples must be provided to the research center prior to initial administration]
• Blood EBV level [Срок оценки: Baseline up to 2 years]
• Evaluate the health-related quality of life (HRQoL) of subjects [Срок оценки: Baseline up to 2 years]

Критерии участия

Критерии включения

• The participants voluntarily signed an informed consent form.
• Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• xpected survival of ≥ 3 months.
• Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
• Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.
• At least one measurable tumor lesion per RECIST 1.1 criteria.
• Adequate organ function.
• Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study.
• The subjects are willing and able to comply with the visit schedule, treatment plan, laboratory examination, and other requirements of the study.

Критерии исключения

• ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.
• Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
• Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.
• Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance).
• Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease.
• Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy.
• Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
• Previously received anti angiogenic therapy.
• According to the judgment of the investigator, there are subjects with concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who believe that there are other reasons that are not suitable for enrollment.

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

Китай · 1 центр

• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT06886347 · ALTN-AK105-Ib-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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