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A real world study for apatinib mesylate tablets combined with chemoradiotherapy in the first-line treatment of advanced esophageal cancer

A real world study for apatinib mesylate tablets combined with chemoradiotherapy in the first-line treatment of advanced esophageal cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000041182
Enrollment
Unknown
Registered
2020-12-20
Start date
2020-12-16
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 cancer

Interventions

Case series:Nil

Sponsors

THE FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Diagnose patients with esophageal squamous cell carcinoma by histopathological and/or immunohistochemical examination; 3. Patients with first-line esophageal squamous cell carcinoma have at least one measurable lesion (CT of tumor lesion Scan long diameter >=10 mm, CT scan of lymph node lesions short diameter >= 15 mm, scan layer The thickness is not more than 6 mm); 4. ECOG score 0-2 points; 5. Estimated survival period >=3 months; 6. The damage caused by the subject receiving other treatments has recovered, including nitroso or silk Schizomycin interval =4 weeks, and The wound has healed completely; the main organs are functioning normally; 7. The main organs function normally, that is, they meet the following standards: (1) The standard of routine blood examination must meet (no blood transfusion and blood products within 14 days): HB >= 80 g/L; ANC >= 1.5x10^9/L; PLT >= 80x10^9/L; (2) Biochemical inspection must meet the following standards: TBIL 45 ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or within 7 days before enrollment Pregnancy test (serum or urine), and the result is negative, and willing to be in the trial period Use appropriate methods of contraception at intervals and 8 weeks after the last administration of the test drug. For men, Appropriate methods must be agreed during the trial and 8 weeks after the last trial drug administration Contraception or surgical sterilization; 9. Subjects voluntarily join the study and sign an informed consent form, with good compliance and cooperation Follow up; 10. The researcher thinks it can benefit.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; suffering from high blood pressure and cannot be reduced to normal after treatment with antihypertensive drugs; Those within the range (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg) suffer from grade I or higher; Upper myocardial ischemia or myocardial infarction, arrhythmia and grade II cardiac insufficiency; 2. There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestines Obstruction etc.; 3. Have a bleeding tendency or are receiving thrombolysis or anticoagulation therapy; 4. With clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood++ above), a history of gastrointestinal bleeding within 6 months; 5. Symptomatic central nervous system metastasis; 6. The investigator judges other conditions that may affect the conduct of clinical research and the determination of research results.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactYihong Chen

THE FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE

1290539349@qq.com+86 139 0553 5176

Outcome results

None listed

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