Study of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM

Official Title
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Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Anlotinib hydrochloride
* Drug: induction chemotherapy
* Radiation: concurrent chemoradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anlotinib<br>3 cycles of anlotinib (12mg, d1-14)was given concurrently with docetaxel plus cisplatin chemotherapy as induction , then 2 additional cycles of anlotinib concurrent with definitive chemoradiation (IMRT with conccurent cisplatin) | Drug: Anlotinib hydrochloride<br>* anlotinib was administered orally 12mg daily for 14 days concurrent with inductive chemotherapy (TP ) for 3 cycles and definitive chemoradiation for additional 2 cycles<br>Drug: induction chemotherapy<br>* docetaxel 75mg/m2 d1 plus DDP 75mg/m2 d1 for 3 cycles every 21days<br>* Other names: IC;Radiation: concurrent chemoradiation<br>* definitive IMRT (GTV>66Gy) concurrent with 2 cycles of DDP (100mg/m2 d1) and anlotinib (12mg d1-14) every 21 days<br>* Other names: CCRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | tumor objective response rate | induction phase ; 3 months after chemoradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | 3year | 
| LRR | local relapse rate | 3 years | 
| RRR | regional relapse rate | 3 years |