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Lanreotide

Oral cabozantinib 40-60 mg/day and lanreotide 120mg deep subcutaneous injection (SC) in day 1 every 4 weeks.

Oral Cabozantinib 40-60 mg daily .every 4 weeks as a cycle

Cabozantinib

Lanreotide 120 mg deep SC on day 1 every 4 weeks.every 4 weeks as a cycle

Ya-Ling Wu, BS

Hui-Jen Tsai, PhD

Chuan-Cheng Wan, PhD

Yen-Yang Chen, PhD

Li-Tzong Chen, PhD

Li-Yuan Bai, PhD

Youngsen Yang, PhD

Yan-Shen Shan, PhD

Tsang-En Wang, MD

Hsiu-Po Wang, PhD

Hsiu-Po Wang

Ming-Hung Chen, PhD

Jia-Hong Chen, PhD

Jen-Shi Chen, PhD

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.

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. The primary objective of the study is to determine the maximal tolerated dose (MTD) of cabozantinib of this combinational regimen in the phase I study and the progression free survival in the phase II study. The secondary objectives are the objective response rate, overall survival, toxicities and biomarker analysis of this regimen.

Eligible patients will receive a combination of oral cabozantinib 40-60 mg/day and lanreotide 120mg deep subcutaneous injection (SC) in day 1 every 4 weeks. Four weeks is a cycle. The patients will continue to receive this regimen till disease progression, intolerable adverse events (after dose modification), death, or withdrawal by patients' or principle investigator's decision.

Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors

A Phase I/II Study Using Cabozantinib and Lanreotide as Treatment for Advanced Gastroenteropancreatic Neuroendocrine Tumors That Failed Molecular Targeted Therapies or Chemotherapy (SCALET)

The dose of maximal tolerated dose of carbozantinib combination of cabozantinib and lanreotide for the recommended dose in phase II study.

The date of first study treatment to the date of disease progression.

Estimates of response category frequencies with 95% confidence intervals will be computed.

the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive.

Treatment toxicities and safety profiles,assessed by CTCAE v5.0

Genetic study assessed by Next Generation Sequencing

Somatic mutation assessed by Next Generation Sequencing

circulating tumor cells assessed by flow cytometry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors	NCT05048901	Neuroendocrine ...	Cabozantinib Lanreotide	20 Years -	National Health Research Institutes, Taiwan
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors	NCT05048901	Neuroendocrine ...	Cabozantinib Lanreotide	20 Years -	National Health Research Institutes, Taiwan
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors	NCT05048901	Neuroendocrine ...	Cabozantinib Lanreotide	20 Years -	National Health Research Institutes, Taiwan

Spots Global Cancer Trial Database for neuroendocrine tumors,gastroenteropancreatic