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A single-arm, prospective, single-center clinical study of Anlotinib hydrochloride capsules for maintenance therapy after radical concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma

A single-arm, prospective, single-center clinical study of Anlotinib hydrochloride capsules for maintenance therapy after radical concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053579
Enrollment
Unknown
Registered
2021-11-24
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

esophageal cancer

Interventions

Sponsors

People's Hospital Affiliated to Hubei University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patients voluntarily participated in this study and signed the informed consent, with good compliance and follow-up; 2. Patients with esophageal squamous cell carcinoma confirmed by histopathology; 3. For patients with clinical stage IIA-IV (cT1-4 b N0-N+ M0), after radical concurrent chemoradiotherapy, the radiotherapy scheme is determined by the investigator according to the patient's condition and according to the''Chinese Radiation Guidelines for Esophageal Cancer or NCCN Guidelines'', concurrent chemotherapy uses the docetaxel + cisplatin regimen (Docetaxel 25mg/m^2 i.v. d1; Cisplatin 25mg/m^2 i.v. d1, q1w, 4-6 cycles); 4. Aged 18-70 years, no gender limit; 5. ECOG PS score of 0-1; expected survival period >= 6 months; 6. No disease progression during radiotherapy and chemotherapy and 2 months after the end of radiotherapy and chemotherapy; 7. Has adequate organ and bone marrow function.

Exclusion criteria

Exclusion criteria: 1. Patients with active bleeding within 2 months; 2. Those with multiple factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 3. Allergic to anlotinib APIs and excipients; 4. Patients with esophageal squamous cell carcinoma who have a stent placed in the esophagus and who are judged by the researchers to be prone to bleeding; 5. Doctors assess patients with esophageal fistula or risk of bleeding; 6. Patients with esophageal squamous cell carcinoma who cannot accept or tolerate oral drugs; 7. Patients who have undergone radiotherapy to the same part of the esophagus in the past; 8. Patients with any severe and/uncontrolled disease.

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS);

Secondary

MeasureTime frame
Overall survival (OS);

Countries

China

Contacts

Public ContactCao Fengjun

People's Hospital Affiliated to Hubei University of Medicine

hbsycfj@126.com+86 13597901600

Outcome results

None listed

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