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A prospective randomized controlled trial on the treatment of locally advanced esophageal squamous cell carcinoma with anlotinib combined with simultaneous radiotherapy and chemotherapy

A prospective randomized controlled trial on the treatment of locally advanced esophageal squamous cell carcinoma with anlotinib combined with simultaneous radiotherapy and chemotherapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040444
Enrollment
Unknown
Registered
2020-11-28
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

esophageal squamous cell carcinoma

Interventions

experimental group:anlotinib combined with simultaneous radiotherapy and chemotherapy
controlled group:simultaneous radiotherapy and chemotherapy

Sponsors

Shandong Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 to 80 years, male and female. 2) Pathological confirmed of esophageal squamous cell carcinoma; 3) TNM stage T3-4N0M0, TxN1-2M0, TxNxM1a (cervical lymph node metastasis); 4) Patients with expected survival >=6 months; 5) KPS >=70; 6) Hemoglobin >= 100g/L, platelet >=100 x 10^9/L, neutrophil >= 1.5x10^9/L; serum creatinine SCR 0.8L; 8) patients must sign informed consent form.

Exclusion criteria

Exclusion criteria: 1) There are contraindications to radiotherapy and chemotherapy (such as active infection, symptomatic heart disease within 6 months after myocardial infarction, including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy); 2) The general condition of the patient is poor, and the KPS score less than 70; 3) Patients who have previously treated with thoracic radiotherapy; 4) Patients who complicate with other malignant tumors.

Design outcomes

Primary

MeasureTime frame
PFS;ORR;

Secondary

MeasureTime frame
the incidence of radiation-induced lung injury;

Countries

China

Contacts

Public ContactXudong Hu

Shandong Cancer Hospital

drhuxudong@163.com+86 18706419949

Outcome results

None listed

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