RecruitingPhase IIEN originalPancreatic cancerMetastatic / advanced

Lenvatinib Plus Chemotherapy for pNET Liver Metastases

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 18-75 lat
  • •Potwierdzony histologicznie lub cytologicznie nowotwór neuroendokrynny trzustki
  • •Przerzuty do wątroby potwierdzone badaniem obrazowym
  • •Progresja choroby po pierwszym leczeniu i kwalifikacja do drugiej linii terapii
  • •Co najmniej jeden mierzalny guz
  • •Dobry stan ogólny (ECOG 0-1)
  • •Prawidłowe funkcje wątroby, nerek i krwi
  • •Oczekiwana długość życia co najmniej 12 tygodni

✗ Disqualifies

  • •Wysoko zaawansowany nowotwór neuroendokrynny lub pochodzący spoza trzustki
  • •Wcześniejsze leczenie lenvatinibem
  • •Niekontrolowana choroba serca lub wysokie ciśnienie krwi
  • •Aktywna ciężka infekcja lub inne niekontrolowane poważne choroby
  • •Przerzuty do mózgu powodujące objawy
  • •Ciąża lub karmienie piersią
  • •Udział w innym badaniu klinicznym mogącym wpłynąć na wyniki

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
September 23, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Chinese Academy of Medical Sciences,Peking Union Medical College Hospital

Beijing, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/24/2026.

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