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Search / Trial NCT03478358

Treatment Using 177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Mar 23, 2018

Trial Information

Current as of July 03, 2025

Unknown status

Keywords

ClinConnect Summary

Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. The most recent NCCN guidelines for unresectable and metastatic NET recommend somatostatin analogues as first-line treatment, but do not recommend a particular treatment sequence for the remaining therapies. Radiolabeled somatostatin analogue therapy, also known as peptide receptor radionuclide therapy has become a well-accepted treatment for patients with well to moderately differentiated unresectable or metastatic NE...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors \[RECIST\]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptorexpressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.
  • Exclusion Criteria:
  • The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.

About Peking Union Medical College Hospital

Peking Union Medical College Hospital (PUMCH) is a prestigious medical institution and a leading research facility located in Beijing, China. Affiliated with the Chinese Academy of Medical Sciences, PUMCH is renowned for its commitment to advancing healthcare through innovative clinical research and high-quality patient care. The hospital plays a pivotal role in the development and execution of clinical trials across various medical disciplines, focusing on improving treatment outcomes and enhancing medical knowledge. With a multidisciplinary team of experts and state-of-the-art facilities, PUMCH is dedicated to contributing to global health advancements and fostering collaborations in the medical research community.

Locations

Beijing, , China

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Zhaohui Zhu, M.D.,PhD

Study Chair

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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