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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib hydrochloride

induction chemotherapy

concurrent chemoradiation

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anlotinib

Arm 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)

Outcomes

Primary Outcome Measures

ORR

tumor objective response rate

Secondary Outcome Measures

PFS

progression-free survival

LRR

local relapse rate

RRR

regional relapse rate

Full Information

NCT ID

NCT05232552

First Posted

May 23, 2021

Last Updated

January 30, 2022

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05232552

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anlotinib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Anlotinib hydrochloride

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

induction chemotherapy

Other Intervention Name(s)

Intervention Description

docetaxel 75mg/m2 d1 plus DDP 75mg/m2 d1 for 3 cycles every 21days

Intervention Type

Radiation

Intervention Name(s)

concurrent chemoradiation

Other Intervention Name(s)

CCRT

Intervention Description

definitive IMRT (GTV>66Gy) concurrent with 2 cycles of DDP (100mg/m2 d1) and anlotinib (12mg d1-14) every 21 days

Primary Outcome Measure Information:

Title

ORR

Description

tumor objective response rate

Time Frame

induction phase ; 3 months after chemoradiation

Secondary Outcome Measure Information:

Title

PFS

Description

progression-free survival

Time Frame

3year

Title

LRR

Description

local relapse rate

Time Frame

3 years

Title

RRR

Description

regional relapse rate

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

feng jiang

Phone

0571-88128202

jiangfeng@zjcc.org.cn

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou,

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

feng jiang

Phone

+86 571 88128201

jiangfeng@zjcc.org.cn

First Name & Middle Initial & Last Name & Degree

xiaozhong Chen

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD could be shared with reasonable reasons

Learn more about this trial

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

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