Lenvatinib plus PD-1 inhibitor for tumors with 11q13 amplification

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study evaluates the safety and potential benefit of lenvatinib combined with a PD-1 inhibitor in adults with unresectable or metastatic solid tumors carrying 11q13 amplification. Participants take lenvatinib by mouth daily and receive a PD-1 inhibitor intravenously every 3 weeks, with regular visits and imaging to track tumor response and side effects. The trial focuses on tumor shrinkage or growth control and tolerability of the combination therapy. Eligible cancers may include esophageal, head and neck, breast, lung, hepatobiliary cancers, and other solid tumors with 11q13 amplification confirmed by NGS.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting
• Tongji Hospital
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Yang WU, M.D.
• Email: 255001907@qq.com
• Phone: 13636076910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.