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Surgery before standard treatment may extend life in cervical cancer

NCT ID NCT04555226

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing whether surgically removing enlarged lymph nodes in the pelvis and abdomen before standard chemoradiation can help people with stage IIICr cervical cancer live longer without the cancer growing. About 452 participants will be randomly assigned to either have the lymph node surgery followed by chemoradiation, or chemoradiation alone. The goal is to see if the surgery improves progression-free and overall survival.

What this could mean

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

Active substance
lymph node dissection (surgery)
What this could lead to
If successful, this could show that removing enlarged lymph nodes before standard chemoradiation helps people with advanced cervical cancer live longer without the disease progressing.
What could go wrong
This is a relatively early-stage trial (Phase not specified) with a moderate size of 452 participants. The surgery itself carries risks like infection, bleeding, or nerve damage, and it may not improve survival compared to chemoradiation alone.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 452 people

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

Started

Jan 2021

Expected to finish

Aug 2032

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 to 70 years

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: 1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma 2. Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm 3. ECOG score 0\~1 4. Expected survival over 6 months 5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial 6. No surgical contraindication Exclusion Criteria: 1. Activity or uncontrol severe infection 2. Active hepatitis B, Liver cirrhosis, Decompensated liver disease 3. History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease 4. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressive medications). Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) were not counted as systemic therapies, and subjects were permitted to use these therapies 5. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis 6. Chronic renal insufficiency or renal failure 7. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated 8. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure 9. Has had an allogenic tissue/solid organ transplant 10. A history of pelvic artery embolization 11. A history of pelvic radiotherapy 12. A history of partial hysterectomy or radical hysterectomy 13. A history of immunotherapy or undergoing immunotherapy 14. A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and/or any excipients 15. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

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Conditions

The condition(s) this trial relates to.

cervical cancer Uterine Cervical Neoplasms

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

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