Skip to content

A single-arm, exploratory, open clinical study of apatinib mesylate in the treatment of patients with oral squamous cell carcinoma who cannot be directly resected

A single-arm, exploratory, open clinical study of apatinib mesylate in the treatment of patients with oral squamous cell carcinoma who cannot be directly resected

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046191
Enrollment
Unknown
Registered
2021-05-09
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Oral squamous cell carcinoma

Interventions

Experimental Group A:Preoperative Apatinib condensation tumor, A: Apatinib single drug 500mg
B: Apatinib combined with other treatment regimen 21 Days postoperatively
Experimental Group B:A: Apatinib single drug 500mg
B: Apatinib combined with other treatment regimen

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years (including 18 and 70 years old); 2. Patients with stage III-IVB locally advanced oral squamous cell carcinoma diagnosed by histology or cytology; 3. Have at least one measurable lesion, and it is confirmed that the lesion is large and cannot be directly removed by surgery; 4. ECOG: 0-2 points; 5. Estimated survival period >= 6 months.

Exclusion criteria

Exclusion criteria: 1. Those who have high blood pressure and cannot fall into the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure > 90 mmHg); 2. Previously suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 450 ms for men and >=470 ms for women); according to NYHA standards, grade 3 to 4 cardiac function Insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 3. Patients with positive urine protein (urinary protein test 2+ or above, or 24-hour urine protein quantitative > 1.0g); 4. Abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN) with bleeding tendency, or those who have had arterial/venous thrombosis within 12 months; 5. Long-term unhealed wounds or fractures; 6. People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 7. According to the judgment of the investigator, there are other patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 8. Pregnant or breastfeeding women; 9. The investigator believes that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;R0 resection rate;

Secondary

MeasureTime frame
Progression-free survival;Total lifetime;

Countries

China

Contacts

Public ContactHan Xinguang

43 University Road, Zhengzhou, He'nan

1803490139@qq.com+86 13526677297

Outcome results

None listed

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