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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Anlotinib hydrochloride; Drug: induction chemotherapy; Radiation: concurrent chemoradiation

• Registration Number: NCT05232552
• Lead Sponsor: Zhejiang Cancer Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-23
• Study First Submitted QC: 2022-01-30
• Last Update Submitted: 2022-01-30
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anlotinib	induction chemotherapy	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)
anlotinib	concurrent chemoradiation	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)
anlotinib	Anlotinib hydrochloride	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)

Primary Outcome Measures

Name	Time	Method
ORR	induction phase ; 3 months after chemoradiation	tumor objective response rate

Secondary Outcome Measures

Name	Time	Method
PFS	3year	progression-free survival
LRR	3 years	local relapse rate
RRR	3 years	regional relapse rate

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou,, Zhejiang, China