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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232552
• Other study ID #: NPC-anlotinib 1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2021
• Source: Zhejiang Cancer Hospital
• Contact: feng jiang
• Phone: 0571-88128202
• Email: jiangfeng[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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

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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou,	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	tumor objective response rate	induction phase ; 3 months after chemoradiation
Secondary	PFS	progression-free survival	3year
Secondary	LRR	local relapse rate	3 years
Secondary	RRR	regional relapse rate	3 years