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A prospective, parallel controlled, randomized, open, single-center clinical study of a novel drug-loaded microsphere in stage IB3-IIA2 cervical cancer

A prospective, parallel controlled, randomized, open, single-center clinical study of a novel drug-loaded microsphere in stage IB3-IIA2 cervical cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054582
Enrollment
Unknown
Registered
2021-12-20
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

cervical cancer

Interventions

Experimental group:Cisplatin-Loaded drug-loaded microspheres for uterine artery embolization combined with paclitaxel systemic intravenous chemotherapy
Control Group:Cisplatin combined with paclitaxel systemic intravenous chemotherapy

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18 to 75 years; 2. PS score =80 mL/min; 8. Adequate blood function: absolute neutrophil count (ANC) >=2x10^9/L, platelet count >=100x10^9/L and hemoglobin >=9g/dL; 9. The subjects voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Those who have received any anti-tumor therapy in the past; 2. Clinically significant cardiovascular disease in patients within 6 months prior to enrollment, including uncontrolled hypertension, myocardial infarction, or unstable angina; New York Heart Association (NYHA) class II or higher congestive heart failure, severe Patients with arrhythmias requiring treatment (including QT interval >= 440 ms), or cardiac ejection fraction 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulation therapy; 4. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, bleeding gastric ulcer, fecal occult blood ++ or above at baseline, or vasculitis; Known hereditary or acquired bleeding and thrombotic tendencies; 5. Arterial/venous thrombotic events within 12 months prior to enrollment; 6. Those who have undergone major surgical operations or associated trauma within 4 weeks of enrollment; 7. History of central nervous system disease, including primary brain tumor, seizures not treated with standard medications, any brain metastases or cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or 6 A history of subarachnoid hemorrhage within a month; 8. Previous or concomitant other malignant tumors; 9. Known history of psychotropic substance abuse, alcoholism or drug use that cannot be eliminated or has a mental disorder; 10. The investigator judges other circumstances that may affect the conduct of clinical research and the judgment of research results.

Design outcomes

Primary

MeasureTime frame
objective response rate;disease control rate;

Secondary

MeasureTime frame
Surgical resection rate;overall survival;Progression-free survival;

Countries

China

Contacts

Public ContactYao Shuzhong

The First Affiliated Hospital of Sun Yat-Sen University

yszlfy@163.com+86 13602834127

Outcome results

None listed

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