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RECRUITING
NCT07835893
PHASE2

Lenvatinib Plus Chemotherapy for pNET Liver Metastases

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01-26

Completion Date

2028-07-01

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DRUG

Lenvatinib

Lenvatinib will be administered as part of second-line treatment in combination with chemotherapy according to the study protocol.

DRUG

Chemotherapy

Chemotherapy will be administered according to the study protocol and clinical characteristics of the participant. The chemotherapy regimen may include an etoposide-platinum regimen or capecitabine plus temozolomide, as specified in the study protocol.

Locations (1)

Chinese Academy of Medical Sciences,Peking Union Medical College Hospital

Beijing, Beijing Municipality, China