Lenvatinib Plus PD-1 Inhibitor for Advanced Solid Tumors With 11q13 Amplification

Официальное название

A Single-Arm, Multicenter, Exploratory Study of Lenvatinib Combined With PD-1 Inhibitor in Advanced Solid Tumors With Chromosome 11q13 Amplification

Обзор

The goal of this clinical trial is to learn if the combination of lenvatinib and a PD-1 inhibitor (a type of immunotherapy) works to treat advanced solid tumors that have a specific genetic change called "11q13 amplification". It will also learn about the safety of this combination. The main questions it aims to answer are: How many participants' tumors shrink or stop growing after receiving the combination therapy? What side effects do participants have when taking this combination therapy? All participants in this study will receive the same drug combination. Researchers will look at the results to see how well the treatment works. Participants will: Take lenvatinib orally once daily and receive PD-1 inhibitor by intravenous infusion every 3 weeks. Visit the clinic regularly for checkups, blood tests, and CT or MRI scans to see how the tumor is responding. Be followed for side effects and survival over time.

Вмешательства

• Препарат Lenvatinib plus PD-1 Inhibitor
  This is a combination therapy. Lenvatinib is administered orally once daily at a weight-based dose (12 mg for patients ≥60 kg; 8 mg for patients \<60 kg). The PD-1 inhibitor component is not fixed; specific agents (such as pembrolizumab, sintilimab, etc.) may be used according to institutional standards and drug availability. The PD-1 inhibitor is administered intravenously at a dose of 200 mg every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or other protocol-

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: From first dose of study treatment until the first documented disease progression or start of new anticancer therapy, whichever occurs first, assessed up to approximately 24 months.]

Вторичные конечные точки (4)

• Disease Control Rate (DCR) [Срок оценки: From first dose until disease progression or start of new therapy, assessed up to 24 months.]
• Progression-Free Survival (PFS) [Срок оценки: From first dose until progression or death, assessed up to 24 months.]
• Overall Survival (OS) [Срок оценки: From first dose until death from any cause, assessed up to approximately 36 months.]
• Incidence of Treatment-Related Adverse Events (TRAEs) [Срок оценки: From first dose until 30 days after the last dose.]

Критерии участия

Критерии включения

• Voluntary signing of the informed consent form, age ≥ 18 years at the time of signing, any gender.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic solid malignant tumor, including but not limited to: esophageal carcinoma, head and neck squamous cell carcinoma, breast cancer, lung cancer, hepatobiliary malignancies, and other solid tumors deemed eligible by the investigator.
• Confirmed tumor presence of chromosome 11q13 amplification (amplification of at least one gene among CCND1, FGF3, FGF4, FGF19) via NGS testing.
• No prior treatment with lenvatinib.
• ECOG Performance Status of 0 or 1, with an estimated life expectancy ≥ 3 months.
• At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter ≥10 mm on CT scan, or lymph node with short axis ≥15 mm).
• Adequate organ function.

Критерии исключения

• Presence of active or previously documented autoimmune or inflammatory disorders.
• Known hypersensitivity to any component of the study drugs (lenvatinib or PD-1 inhibitors).
• Significant bleeding tendency or coagulation dysfunction, or occurrence of major bleeding within 4 weeks prior to enrollment.
• Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) despite medication.
• Received chemotherapy, radiotherapy, major surgery, or other anticancer therapy within 4 weeks prior to enrollment.
• Pregnant or lactating women, or patients of childbearing potential unwilling to use effective contraception.
• Inability to comply with the study protocol for treatment or scheduled follow-up assessments.

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

• Tongji Hospital — Ухань

Идентификаторы

NCT: NCT07417501 · LEN-PD1-11q13-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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