Phase
Condition
Melanoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age more than 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Pathologically confirmed diagnosis of mucosal melanoma;
Completely resected primary tumor (once regional lymph nodes were involved, diagnosedby clinical or imaging examinations, lymphadenectomy was conducted);
No prior systemic adjuvant therapy or regional radiotherapy;
No evidence of distant metastatic disease evaluated by means of lymph nodesultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract,single-photon emission computed tomography (CT) of bone, and whole-body spiral CT orpositron emission tomography-CT (PET-CT);
Normal bone marrow function; and adequate liver and renal function [including whiteblood cell (WBC) count > 3,000/mm^3;absolute neutrophil count > 1,500/mm^3; platelets >100,000/mm^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) andalanine aminotransferase (ALT) less than 2.5 times of ULN; international normalizedratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN].
Exclusion
Exclusion Criteria:
Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;
Incomplete resection or primary tumor unable to be resected;
A second cancer diagnosis;
Definite medical history of cirrhoses of the liver or autoimmune diseases;
Severe depression; and pregnant or lactating female.
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, 100142
ChinaActive - Recruiting
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