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A real world study for assessment of the effect and safety of apatinib mesylate in the treatment of advanced esophageal cancer

A real world study for assessment of the effect and safety of apatinib mesylate in the treatment of advanced esophageal cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040062
Enrollment
Unknown
Registered
2020-11-19
Start date
2020-11-15
Completion date
Unknown
Last updated
2021-01-05

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:Apatinib mesylate tablets monotherapy/combined chemotherapy/combined radiotherapy/combined immunotherapy

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years old; 2. Patients with esophageal cancer diagnosed by histopathological and/or immunohistochemical examination; 3. Patients with primary esophageal lesions undergoing chemotherapy or radiotherapy, patients with or without surgery (except for high-risk groups); patients with or without primary lesions (the lesions are close to large blood vessels or trachea, ulcer-type lesions), Anastomotic recurrence is not recommended to be included in the group); 4. ECOG score: 0-2 points; 5. Estimated survival period>=3 months; 6. The subject has recovered from the damage caused by other treatments, received other cytotoxic drugs, radiotherapy or surgery for >=3 weeks, and the wound has healed completely; 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) The biochemical inspection shall meet the following standards: TBIL 45 ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or taken a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to adopt appropriate methods during the trial and 8 weeks after the last trial drug administration contraception. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9. The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with high blood pressure who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg) with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia, and grade II heart Insufficiency; 3. There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 4. Have a bleeding tendency or are receiving thrombolysis or anticoagulation therapy; 5. Have a clear gastrointestinal bleeding concern (such as local active ulcer lesions, stool occult blood++ or more), a history of gastrointestinal bleeding within 6 months; 6. Symptomatic central nervous system metastasis; 7. 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 ContactGuoping Sun

The Affiliated First Hospital of Anhui Medical University

1290539349@qq.com+86 13805609309

Outcome results

None listed

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