Radiotherapy Combined With Endostatin and Capecitabine for NPC
NCT ID: NCT05514275
Last Updated: 2022-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
41 participants
INTERVENTIONAL
2022-08-01
2028-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endostatin and Capecitabine
Patients received radiotherapy Combined With Endostatin and Capecitabine
Endostatin and Capecitabine
Patients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles)
Interventions
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Endostatin and Capecitabine
Patients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles)
Eligibility Criteria
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Inclusion Criteria
Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).
No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) \> 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.
unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT)
Exclusion Criteria
Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
18 Years
65 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Jin Ting
MD
Principal Investigators
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Ting Jin, MD
Role: STUDY_CHAIR
Department of Radiation Oncology, Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
the First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Central Hospital
Jinhua, Zhejiang, China
The Central Hospital of Lishui City
Lishui, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Ningbo Medical Center Lihuili Eastern Hospital
Ningbo, Zhejiang, China
People's Hospital of Quzhou
Quzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Binbin Song
Role: primary
Shubo Ding
Role: primary
Zhifeng Tian, MD
Role: primary
Pengrong Lou
Role: primary
Yi Lu
Role: primary
Zheng Peng
Role: primary
Other Identifiers
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RCECNPC
Identifier Type: -
Identifier Source: org_study_id
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