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

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05232552
Collaborator
(none)
37
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Anlotinib hydrochloride
  • Drug: induction chemotherapy
  • Radiation: concurrent chemoradiation
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: anlotinib

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
anlotinib was administered orally 12mg daily for 14 days concurrent with inductive chemotherapy (TP ) for 3 cycles and definitive chemoradiation for additional 2 cycles

Drug: induction chemotherapy
docetaxel 75mg/m2 d1 plus DDP 75mg/m2 d1 for 3 cycles every 21days
Other Names:
  • IC

    • Radiation: concurrent chemoradiation
    definitive IMRT (GTV>66Gy) concurrent with 2 cycles of DDP (100mg/m2 d1) and anlotinib (12mg d1-14) every 21 days
    Other Names:
  • CCRT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ORR [induction phase ; 3 months after chemoradiation]

      tumor objective response rate

    Secondary Outcome Measures

    1. PFS [3year]

      progression-free survival

    2. LRR [3 years]

      local relapse rate

    3. RRR [3 years]

      regional relapse rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhejiang Cancer Hospital Hangzhou, Zhejiang China 310022

    Sponsors and Collaborators

    • Zhejiang Cancer Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chen Xiaozhong, Director, Head of Radiation department, Principal Investigator, Clinical Professor, Zhejiang Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05232552
    Other Study ID Numbers:
    • NPC-anlotinib 1
    First Posted:
    Feb 10, 2022
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Nasopharyngeal Carcinoma

    Study Results

    No Results Posted as of Feb 10, 2022