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A randomized, open and prospective clinical study to evaluate the HPV conversion efficacy of Xixiai on HPV-positive cervical high-grade squamous intraepithelial lesion (HSIL) patients after cervical conization

A randomized, open and prospective clinical study to evaluate the HPV conversion efficacy of Xixiai on HPV-positive cervical high-grade squamous intraepithelial lesion (HSIL) patients after cervical conization

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045909
Enrollment
Unknown
Registered
2021-04-27
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

High-grade squamous intraepithelial lesion

Interventions

Treatment group:Xixiai

Sponsors

The Second Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in the study, and has signed the informed consent.; 2. Aged >=18 years(including the cut-off value) with sexual life history; 3. HPV were positive by HPV test (Kaipu) ; 4. The histopathology of cervical biopsy was HSIL and received cervical conization (including cold knife conization and LEEP); 5. Postoperative histopathology was negative margins; 6. Had not received anti-HPV system treatment after cervical conization; 7. Agree to take contraceptive measures before the 12th month visit after completion of treatment.

Exclusion criteria

Exclusion criteria: 1. Histopathology suggested cervical cancer; 2. Have had other uncured malignant tumors in the past 5 years or at the same time; 3. During pregnancy or lactation; 4. Suffering from severe pelvic inflammation, severe cervicitis, bleeding disease or other uncontrolled diseases; 5. Childbirth or miscarriage occurred within 6 weeks before enrollment; 6. Patients with severe heart, lung, liver and kidney diseases; 7. Suffering from severe autoimmune diseases, such as AIDS, systemic lupus erythematosus, ankylosing spondylitis, Sjogrens syndrome, rheumatoid arthritis, Hashimotos thyroiditis, etc.; 8. Have used corticosteroids, immune preparations, immunomodulators or other drugs that act on the immune system within 12 weeks; 9. Long-term oral contraceptives; 10. Allergic to egg yolks or research drugs; 11. The patient has active infection and fever of unknown origin within 7 days before randomization >= 38.5?; 12. Accompanied by epilepsy or other mental illnesses.

Design outcomes

Secondary

MeasureTime frame
Adverse Event, AE;

Primary

MeasureTime frame
HPV response rate;

Countries

China

Contacts

Public ContactXu Zhen

The Second Affiliated Hospital of Zhengzhou University

xuzhen413@126.com+86 13526723128

Outcome results

None listed

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