Actively Recruiting
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
Led by National Health Research Institutes, Taiwan · Updated on 2026-04-09
49
Participants Needed
11
Research Sites
328 weeks
Total Duration
On this page
Sponsors
N
National Health Research Institutes, Taiwan
Lead Sponsor
N
National Taiwan University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy.
CONDITIONS
Official Title
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed G1 or G2 gastroenteropancreatic neuroendocrine tumor (GEP-NET) with advanced or metastatic disease who failed one or more lines of small molecule kinase inhibitor treatment, or well-differentiated G3 GEP-NET who failed one or more lines of chemotherapy or kinase inhibitors.
- Radiologic progression within 12 months before enrollment.
- Recovery to baseline or Grade 1 or less toxicity from previous treatments, unless stable and clinically non-significant.
- Age 20 years or older with ECOG Performance Status of 0 or 1.
- Adequate organ and marrow function based on specific laboratory tests within 14 days before first treatment.
- At least one measurable lesion by RECIST 1.1 outside locally treated sites.
- Life expectancy greater than 12 weeks.
- Ability to understand and comply with study requirements and provide informed consent.
- Female participants of childbearing potential and their partners must agree to use effective contraception during and for 4 months after treatment.
- Female participants must not be pregnant at screening and must meet specific criteria to confirm non-childbearing potential.
You will not qualify if you...
- Previous use of cabozantinib (prior lanreotide use is allowed).
- Use of any small molecule kinase inhibitor within 2 weeks or five half-lives before treatment.
- Use of anticancer antibodies or systemic chemotherapy within 4 weeks before treatment.
- Radiation therapy within 2 to 6 weeks before treatment, depending on type and site.
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks without symptoms or corticosteroids.
- Use of certain anticoagulants, except specified allowed agents.
- Significant uncontrolled illnesses including severe heart failure, unstable angina, serious arrhythmias, uncontrolled hypertension, recent heart attack or stroke within 6 months.
- Gastrointestinal disorders with high risk of perforation or fistula, recent abdominal complications within 6 months.
- Major surgery within 4 weeks or incomplete wound healing.
- Significant bleeding events within 12 weeks before treatment.
- Cavitating pulmonary lesions or major blood vessel invasion by tumor.
- Other serious disorders preventing safe participation, including serious non-healing wounds, symptomatic hypothyroidism, moderate to severe liver impairment.
- QTc interval over 500 ms on ECG within 14 days before treatment.
- Pregnant or breastfeeding females.
- Inability to swallow tablets.
- Known allergy to study treatment components.
- Any other active cancer requiring treatment, except certain cured local cancers.
- Mental status unsuitable for clinical trial participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Changhua Christian Hospital
Changhua, Taiwan
Actively Recruiting
2
Chang Gung Medical Foundation
Kaohsiung City, Taiwan
Actively Recruiting
3
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
4
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
5
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
6
National Cheng Kung University Hospita
Tainan, Taiwan
Actively Recruiting
7
Mackay Memorial Hospital
Taipei, Taiwan
Actively Recruiting
8
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
9
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
10
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
11
Chang Gung Medical Foundation
Taoyuan, Taiwan
Actively Recruiting
Research Team
Y
Ya-Ling Wu, BS
CONTACT
H
Hui-Jen Tsai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here