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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
ChiCTR2100045471
Enrollment
Unknown
Registered
2021-04-16
Start date
2021-04-15
Completion date
Unknown
Last updated
2021-11-29

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

Yijishan Hospital, Wannan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, no gender limit; 2. Patients with esophageal squamous cell carcinoma confirmed by histopathological and/or immunohistochemical examination; 3. Patients with first-line esophageal squamous cell carcinoma have at least one measurable lesion (the CT scan length of the tumor lesion is >= 10 mm, the CT scan length of the lymph node lesion is >=15 mm, and the scan thickness is not greater than 6 mm); 4. ECOG score: 0-2 points; 5. The expected survival period is >= 3 months; 6. The damage caused by the subject receiving other treatments has recovered, among which the interval between receiving nitroso or mitomycin is = 4 weeks, and the wound has healed completely; main organ function normal; 7. The main organs are functioning normally, that is, they meet the following standards: (1) Routine blood examination standards must meet (no blood transfusion and blood products within 14 days): 1) HB >= 80 g/L; 2) ANC >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; (2) The biochemical inspection shall meet the fol lowing standards: 1) TBIL 45 ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or undergo 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 subject voluntarily joins the study and signs an informed consent form, with good compliance and cooperation with follow-up; 10. The researcher believes that 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
Progression-free survival;

Countries

China

Contacts

Public ContactChen Yihong

Yijishan Hospital, Wannan Medical College

1290539349@qq.com+86 13905535176

Outcome results

None listed

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