Nasopharyngeal Carcinoma
Conditions
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
Interventions
DRUGAnlotinib hydrochloride
anlotinib was administered orally 12mg daily for 14 days concurrent with inductive chemotherapy (TP ) for 3 cycles and definitive chemoradiation for additional 2 cycles
DRUGinduction chemotherapy
docetaxel 75mg/m2 d1 plus DDP 75mg/m2 d1 for 3 cycles every 21days
RADIATIONconcurrent chemoradiation
definitive IMRT (GTV\>66Gy) concurrent with 2 cycles of DDP (100mg/m2 d1) and anlotinib (12mg d1-14) every 21 days
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ; 2. N2-3 disease (UICC/AJCC 8th) with necrosis or/and ECM; 3. with sufficient organ and bone marrow function; 4. ECOG (Eastern US Cooperative Oncology Group) score \< 3 5. with good compliance and cooperation to treatment and follow-up 6. agree to use effective methods of contraception during the study period and within 180 days of the last study administration.
Exclusion criteria
1. patients with other malignant tumors diagnosed within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\] 2. patients with bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers or fracture; 3. 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. 4. 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). 5. 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. 6. serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study 7. Allergy to the drugs in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | induction phase ; 3 months after chemoradiation | tumor objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3year | progression-free survival |
| LRR | 3 years | local relapse rate |
| RRR | 3 years | regional relapse rate |
Countries
China
Contacts
Primary Contactfeng jiang
Outcome results
None listed