Lenvatinib plus chemotherapy for pancreatic neuroendocrine tumors with liver metastases

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 is a phase 2, non-randomized, concurrent parallel-controlled trial evaluating two second-line treatment strategies in pancreatic neuroendocrine tumor patients with liver metastases. Participants will receive either lenvatinib plus chemotherapy or chemotherapy alone, with outcomes including objective response rate, progression-free survival, overall survival, and treatment-related adverse events. Blood samples will be collected at multiple time points to study molecular and immune changes associated with response and resistance, focusing on cfDNA and PBMCs. The study aims to understand mechanisms of primary and acquired resistance and to characterize safety and efficacy of the treatment regimens. Enrollment is limited to adults aged 18–75 with adequate organ function and measurable disease, who progressed after first-line therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Inclusion Criteria:
* Age 18 to 75 years.
* Histologically or cytologically confirmed pancreatic neuroendocrine tumor.
* Radiologically confirmed liver metastases.
* Disease progression or treatment failure after first-line systemic therapy, with eligibility for second-line treatment.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic, and renal function as assessed by the investigator.
* Life expectancy of at least 12 weeks.
* Ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

* Poorly differentiated neuroendocrine carcinoma or neuroendocrine tumor originating from a site other than the pancreas.
* Previous treatment with lenvatinib.
* Uncontrolled or clinically significant cardiovascular disease, including uncontrolled hypertension.
* Active severe infection or other uncontrolled serious systemic disease.
* Known central nervous system metastases that are symptomatic or uncontrolled.
* Pregnancy or breastfeeding.
* Participation in another interventional clinical study that may interfere with the outcomes of this study.
* Any other condition that, in the opinion of the investigator, may make the participant unsuitable for participation in this study.

Where it's running

• Chinese Academy of Medical Sciences，Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

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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.