Lenvatinib Plus Chemotherapy for pNET Liver Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lenvatinib
DrugLenvatinib will be administered as part of second-line treatment in combination with chemotherapy according to the study protocol.
Chemotherapy
DrugChemotherapy 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Lenvatinib Plus ChemotherapyExperimental treatment 1 intervention
Group B: Chemotherapy AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as their best overall response, as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame
From treatment initiation until disease progression, death, or up to 24 monthsSecondary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from treatment initiation to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame
From treatment initiation until disease progression or death, whichever occurs first, assessed up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov