Status:
UNKNOWN
Study of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM
Eligibility Criteria
Inclusion
- newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ;
- N2-3 disease (UICC/AJCC 8th) with necrosis or/and ECM;
- with sufficient organ and bone marrow function;
- ECOG (Eastern US Cooperative Oncology Group) score \< 3
- with good compliance and cooperation to treatment and follow-up
- agree to use effective methods of contraception during the study period and within 180 days of the last study administration.
Exclusion
- patients with other malignant tumors diagnosed within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\]
- patients with bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers or fracture;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C.
- Active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin \>38.5℃ 1 weeks ago (except for tumor related fever determined by researchers).
- Abnormal coagulation (INR \> 1.5 or APTT \> 1.5 × ULN), bleeding tendency or undergoing thrombolysis or anticoagulation. Long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy is required.
- serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study
- Allergy to the drugs in the study
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05232552
Start Date
January 1 2021
End Date
December 31 2024
Last Update
February 10 2022
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022