Pancreatic Neuroendocrine Tumor With Liver MetastasesPhase 2LEN-pNETNCT07835893
Lenvatinib Plus Chemotherapy for pNET Liver Metastases
A Phase 2 study testing Lenvatinib and Chemotherapy in people with Pancreatic Neuroendocrine Tumor With Liver Metastases, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neuroendocrine Tumor With Liver Metastases
- What is being tested?
- Lenvatinib and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2026to 1 Jul 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- 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.
- Any other condition that, in the opinion of the investigator, may make the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences，Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Jiayue Li, 86+010-6915687, 1624271942@qq.com
About this study
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
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.
- Being tested
- Lenvatinib, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Lenvatinib will be administered as part of second-line treatment in combination with chemotherapy according to the study protocol.
ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib Plus Chemotherapy | Experimental | Not described Receives: Drug: Lenvatinib |
| Chemotherapy Alone | Active comparator | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From treatment initiation until disease progression, death, or up to 24 months
Secondary 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.
Measured: From treatment initiation until disease progression or death, whichever occurs first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start26 Jan 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine Tumor With Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835893
- Sponsor's protocol ID
- NET001
- Acronym
- LEN-pNET
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No