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

A prospective, parallel controlled, randomized, open, single-center clinical study of uterine arterial chemoembolization with cisplatin loaded microspheres combined with radical radiotherapy versus concurrent chemoradiotherapy in the treatment of stage IIB to IIIB cervical cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054519
Enrollment
Unknown
Registered
2021-12-19
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

Control group:Interventional chemotherapy
Experimental group: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. No serious heart, lung and other vital organ dysfunction; 10. 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 anticoagulant 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 13602384127

Outcome results

None listed

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