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

NCT05232552 | Unknown Phase 2

• 1 other identifier: NPC-anlotinib 1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  tumor objective response rate

  induction phase ; 3 months after chemoradiation

Secondary Outcomes (3)

• PFS

  3year

• LRR

  3 years

• RRR

  3 years

Study Arms (1)

anlotinib

EXPERIMENTAL

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; Drug: induction chemotherapy; Radiation: concurrent chemoradiation

Interventions

Anlotinib hydrochloride DRUG

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

anlotinib

induction chemotherapy DRUG

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

Also known as: IC

anlotinib

concurrent chemoradiation RADIATION

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

Also known as: CCRT

anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Induction Chemotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Central Study Contacts

feng jiang

CONTACT

0571-88128202; jiangfeng@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Radiation department, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: February 10, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: February 10, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)