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Prospective, single-center, randomized controlled study of efficacy and safety of drug-loaded microspheres D-TACE in the treatment of unresectable cervical cancer

Prospective, single-center, randomized controlled study of efficacy and safety of drug-loaded microspheres D-TACE in the treatment of unresectable cervical cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060692
Enrollment
Unknown
Registered
2022-06-08
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-06-03

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:D-TACE+Standard chemoradiotherapy

Sponsors

Lishui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged 18-75, with no gender limitation; 2) Cervical cancer was diagnosed clinically by histopathological and cytological examination; 3) Patients who have no clinical indications for surgery and cannot be surgically resected or refused surgery; 4) Physical fitness ECOG-PS <=1; 5) The expected survival time is more than 3 months; 6) There is at least one evaluable lesion in the lesion, and the diameter of the lesion can be measured; 7) Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1) Distant metastasis of tumor; 2) those who have had or are currently having other malignant tumors (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix); 3) Patients in the experimental group with tumor supplying artery overselection failure; 4) a history of major diseases involving the heart, kidney, bone marrow or lung or central nervous system; 5) Recent infections requiring antibiotic treatment; 6) Abnormal liver and kidney functions (transaminase was 5 times the normal value, bilirubin increased 50 mmol/L, albumin < 28 g/L, creatinine clearance < 50 mL/min); 7) Abnormal coagulation function, marked reduction of peripheral white blood cells and platelets (WBC < 3*10^9/L, platelets < 50*10^9/L), which cannot be corrected; 8) Patients with contraindications for vascular intervention, contrast agents or study drugs; 9) Pregnant or lactating women, or fertile women who are unwilling or unable to take effective contraceptive measures; 10) Participating in other clinical trials or judging by other researchers that may affect the conduct of the clinical study and the determination of the study results.

Design outcomes

Primary

MeasureTime frame
Progression-free Survival;

Secondary

MeasureTime frame
Overall Survival;Objective Response Rate;Disease Control Rate;Duration of Response;

Countries

China

Contacts

Public ContactZhongwei Zhao

Lishui Central Hospital

zhaozw79@163.com+86 15925728781

Outcome results

None listed

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