177Lu-EB-LM3 in Nasopharyngeal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-EB-LM3 in patients with advanced metastatic nasopharyngeal carcinoma. Different groups with doses of 1.11GBq(1.11GBq)(30 mCi) and 2.22GBq(2.22GBq) (60 mCi)of 177Lu-EB-LM3 will be injected intravenously. All patients will undergo 68Ga-DOTA-Octreotide(TATE) PET/CT scans before and after the treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Criteria

Inclusion Criteria:

• Adults who had NPCs and had metastasized, that were with histologically confirmed,SSTR-positive cancers and inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors [RECIST]. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptor expressing 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 glomerular filtration rate(GFR) of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA(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.