NCT07835893RecruitingPhase 2
Lenvatinib Plus Chemotherapy for pNET Liver Metastases
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
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- Jan 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT07835893
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From Jan 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with lenvatinib.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.