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

University of Chinese Academy Sciences

Status and phase: Enrolling; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: concurrent chemoradiation; Drug: induction chemotherapy; Drug: Anlotinib hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05232552

NPC-anlotinib 1

Details and patient eligibility

About

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

Enrollment: 37 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

anlotinib

Experimental group

Description:

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)

Treatment:

Drug: induction chemotherapy

Radiation: concurrent chemoradiation

Drug: Anlotinib hydrochloride