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

Inclusion criteria

• 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.

Exclusion criteria

• 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.