Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a Light-Activated cream replace surgery for cervical precancer?

NCT ID NCT07669363

Disease control Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 6 times

Summary

This study tests a new approach for treating high-grade cervical precancer (HSIL) using a cream called HAL that is activated by a special light, instead of standard surgery. About 230 women will be randomly assigned to receive either the light therapy or surgery. The main goal is to see if the cream can clear the abnormal cells as effectively as surgery, while possibly being gentler and preserving fertility.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hexaminolevulinate hydrochloride (HAL) 5% ointment with light therapy
What this could lead to
If successful, this could offer a non-surgical, outpatient option for treating cervical precancer, potentially preserving fertility and reducing recovery time.
What could go wrong
This is an early Phase II trial with only 230 participants, so results may not apply broadly. The treatment may not be as effective as surgery, and there is a small risk of progression to cancer if it fails.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 days and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily participate in this clinical study, fully understand the study content, procedures, and potential adverse reactions, and be able to sign the written informed consent form. * Able to complete the study in accordance with the study protocol. * Subject age ≥18 years. * Presence of High-Grade Squamous Intraepithelial Lesion (HSIL) (CIN2 P16 positive/CIN3), specifically: HSIL with histopathological diagnosis of grade II/III (CIN2 P16 positive/CIN3) within 3 months prior to the first treatment. * Adequate colposcopy, including: (a) Complete visibility of the cervical transformation zone, including the squamocolumnar junction; (b) Complete visibility of lesion margins. * The investigator determines that non-surgical treatment is acceptable for the participant. * The investigator determines that the cervical size is suitable for placement of the HAL-PDT device. * Meets the following conditions: Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result prior to the start of treatment. No plan for pregnancy during the study period; no sexual activity or use of effective and reliable contraception from the end of the last menstrual period to the start of the study, and agreement to use condoms for barrier contraception during the study period. WOCBP is defined as a female who has experienced menarche, has not undergone hysterectomy or bilateral oophorectomy, and has not reached natural menopause (i.e., no menstruation at all for the past 24 consecutive months). Exclusion Criteria: * Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions. * CIN2 with P16 negative. * Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva. * Prior physical or surgical treatment to the cervix resulting in incomplete cervical structure (e.g., cold knife conization), or receipt of physical or surgical therapy for CIN2 or CIN3 after the current histopathological diagnosis. * The first study treatment day falls within 7 half-lives of the last antiviral medication. * Severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infectious diseases found on colposcopic or clinical examination. * Investigator judges that vaginal bleeding during treatment may affect treatment outcomes. * Receipt of any inactivated vaccine within 2 weeks prior to the first treatment, or any live vaccine within 4 weeks prior to the first treatment. * Previous severe cardiovascular, cerebrovascular, neurological, psychiatric, endocrine, or hematopoietic disease that has not been cured; known severely compromised immune function, or need for long-term use of corticosteroids or immunosuppressants; history of malignancy within 5 years. * History of clinically significant immunosuppression or confirmed autoimmune disease; or primary immunodeficiency. * Known or newly identified active sexually transmitted diseases (STDs), including but not limited to HIV, syphilis, genital herpes, unless adequately treated and tested negative before study treatment. * Presence of a cardiac pacemaker. * Suspected or known porphyria, or known allergy to the study drug, its chemically similar compounds, or photosensitizers. * Allergy to silicone. * Pregnant or breastfeeding women. * Delivery or miscarriage within 6 weeks prior to enrollment. * Participation in any other clinical trial within 30 days prior to study treatment. * Poor compliance or judged by the investigator to be unsuitable for participation in this clinical study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cervical intraepithelial neoplasia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 dysplasia of cervix human papilloma virus infection squamous cell intraepithelial neoplasia Squamous Intraepithelial Lesions uterine cervix carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical intraepithelial neoplasia Papillomavirus infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

    Hangzhou, Zhejiang, 310022, China

  • Dongguan Maternal and Child Health Care Hosptial

    Dongguan, Guangzhou, 523000, China

  • Foshan Shunde Maternal and Child Health Hospital

    Foshan, Guangdong, 528300, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Guangdong ProvincialHospital of Chinese Medicine

    Guangzhou, Guangdong, 510120, China

  • Guangdong Second Provincial GeneralHospital (Guangdong Provincial Emergency Hospital)

    Guangzhou, Guangdong, 510317, China

  • Guangdong Women and Children Hospital

    Guangzhou, Guangdong, 510010, China

  • Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital

    Nanning, Guangxi, 530000, China

  • Guangzhou First People's Hospital (The Second Affiliated Hospital of South China University of Technology)

    Guangzhou, Guangdong, 510180, China

  • Guangzhou Women and Children's Medical Center (The Affiliated Women and Children's Medical Center of Guangzhou Medical University)

    Guangzhou, Guangdong, 510623, China

  • Panyu Central Hospital Affiliated to Guangzhou Medical University

    Guangzhou, Guangdong, 511400, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000, China

  • Shenzhen Maternity and Child Health Hospital

    Shenzhen, Guangdong, 518031, China

  • The Affiliated Cancer Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510095, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital with Nanjing Medical University (Jiangsu Provincial People's Hospital)

    Nanjing, Jiangsu, 210029, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Zhongshan, Guangdong, 510080, China

  • The First AffiliatedHospital, Guangzhou University ofTraditional Chinese Medicine

    Guangzhou, Guangdong, 510405, China

  • The First Hospital of Jilin University

    Changchun, Jinlin, China

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000, China

  • The General Hospital of Northern Theater Command of the Chinese People's Liberation Army

    Shenyang, Liaoning, 110016, China

  • The West China Second University Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiamen Maternity and Child Healthcare Hospital

    Xiamen, Fujian, 361001, China

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510280, China

  • he First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.