Overview

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

Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
Summary
anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang Cancer Hospital
Criteria
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