Concurrent chemoradiotherapy combined with anlotinib in patients with locoregionally advanced nasopharyngeal carcinoma: a multicenter randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900022969

Enrollment

Unknown

Registered

2019-05-05

Start date

2019-07-01

Completion date

Unknown

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal carcinoma

Interventions

Experimental arm:Concurrent chemoradiotherapy combined with Anlotinib

Control arm:Concurrent chemoradiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients of either gender and aged from 18 to 70 years old; 2. Karnofsky performance score = 70; 3. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (according to World Health Organization (WHO) histologically type); 4. Patients at stage III or IVa (AJCC 8th edition); 5. Adequate renal and hepatic function; 6. Adequate bone marrow function ( white blood cells > 4.0×10^9/L; absolute neutrophil count > 2.0 × 10^9/L, hemoglobin > 90g/L; platelets > 100×10^9/L); 7. Pathologically newly diagnosed NPC with no prior anti-tumor therapy and with measurable tumor lesions; 8. Expected survival =6 months; 9. Patients willing to be followed up regularly; 10. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Other malignancy before inclusion, except for non-melanocytoma skin cancer, carcinoma in situ of the cervix; 2. Previously received anti-tumor therapy including radiotherapy, chemotherapy or surgery; 3. Pregnancy or breast feeding; 4. Simultaneous participation in another clinical study; 5. Inadequate organ function; 6. Patients unable to be followed up regularly; 7. Patients with an absolute contraindication to MRI; 8. The prescription dose preconditions cannot be satisfied; 9. Bleeding symptoms with significant clinical significance or a clear tendency to bleeding were observed; 10. The researchers determined that other causes could not be included.

Design outcomes

Primary

Measure	Time frame
Failure-free survival(FFS);	—

Secondary

Measure	Time frame
Locoregional recurrence-free survival (LRFS);Distant metastasis-free survival (DMFS);Overall survival (OS);Complete respond rate;Safety;	—

Countries

China

Contacts

Public ContactXu Yaocan

Guiping People's Hospital

xuyc.cn@outlook.com+86 17376359808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026