Lenvatinib with chemotherapy for pancreatic neuroendocrine tumors that spread to the liver
Tests lenvatinib plus chemotherapy against chemotherapy alone in adults whose first treatment failed.
Plain-language title generated from the registry record
Registry title: Lenvatinib Plus Chemotherapy for pNET Liver Metastases
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07835893, who can take part
Where in China
- Chinese Academy of Medical Sciences & Peking Union Medical College HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07835893
- Record updated
- 23 September 2026
- Original description
This prospective, non-randomized, concurrent parallel-controlled study will evaluate treatment response and resistance mechanisms in patients with pancreatic neuroendocrine tumors with liver metastases (pNET-LM) receiving second-line systemic therapy after failure of first-line treatment.Read full original descriptionShow less
A Study of Second-Line Treatment Response and Resistance Mechanisms in Pancreatic Neuroendocrine Tumors With Liver Metastases Based on cfDNA and Single-Cell PBMC Multi-omics
This prospective, non-randomized, concurrent parallel-controlled study will evaluate treatment response and resistance mechanisms in patients with pancreatic neuroendocrine tumors with liver metastases (pNET-LM) receiving second-line systemic therapy after failure of first-line treatment.
Eligible patients will receive either lenvatinib combined with chemotherapy or chemotherapy alone according to the study protocol and clinical treatment strategy. The clinical efficacy and safety of the two treatment strategies will be evaluated using objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.
Peripheral blood samples will be collected before treatment, during early treatment, and at disease progression. Circulating cell-free DNA (cfDNA) and peripheral blood mononuclear cells (PBMCs) will be analyzed to investigate molecular and immune changes associated with treatment response, primary resistance, and acquired resistance. The study aims to identify potential biomarkers for predicting treatment response and to improve understanding of resistance mechanisms in pNET-LM.
Inclusion: 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: Previous treatment with lenvatinib; Uncontrolled or clinically significant cardiovascular disease, including uncontrolled hypertension; Active severe infection or other uncontrolled serious systemic disease; Any other condition that, in the opinion of the investigator, may make the participant unsuitable for participation in this study; Poorly differentiated neuroendocrine carcinoma or neuroendocrine tumor originating from a site other than the pancreas; 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.