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New drug combo aims to boost cervical cancer survival

NCT ID NCT07649174

Disease control Sponsor: Obstetrics & Gynecology Hospital of Fudan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase II trial tests whether adding the immunotherapy drug cadonilimab to chemotherapy before surgery helps people with locally advanced cervical cancer live longer without the disease coming back. About 134 participants will be randomly assigned to receive either the drug combo plus surgery or standard chemoradiotherapy. The main goal is to see if the new approach improves the two-year progression-free survival rate.

What this could mean

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

Active substance
cadonilimab (an immunotherapy drug) plus chemotherapy
What this could lead to
If it works, this could offer a more effective treatment approach for locally advanced cervical cancer, potentially improving the chance of staying cancer-free after surgery.
What could go wrong
This is an early Phase II trial with only 134 participants, so results may not apply to everyone. Immunotherapy can cause side effects like immune reactions, and the combination may not prove better than standard chemoradiotherapy.

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 134 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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 75 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. Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter \>4 cm as assessed by contrast-enhanced pelvic MRI); 2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 3. Female patients aged ≥18 and ≤75 years; 4. Willing and able to provide written informed consent and comply with study visits and protocol-required procedures; 5. Eligible for radical hysterectomy with curative intent; 6. At least one measurable lesion according to RECIST version 1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 8. Estimated life expectancy of at least 6 months; 9. Women of childbearing potential must agree to use effective contraception throughout the study period. A negative serum or urine pregnancy test is required before study enrollment. Exclusion Criteria: 1. Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma. 2. Clinically significant unrecoverable hydronephrosis; 3. CNS metastases or leptomeningeal disease; 4. Active malignancy within 3 years prior to enrollment (with specified exceptions); 5. Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies; 6. Major surgery within 4 weeks before study treatment; 7. Severe cardiovascular or cerebrovascular disease; 8. Unresolved toxicities from previous anticancer therapy (\> Grade 1, CTCAE v5.0); 9. Known hypersensitivity to study drugs; 10. Serious medical or psychiatric conditions that may interfere with study participation; 11. Pregnancy.

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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.

Cervical cancer

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

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, 201101, China

More trials for these conditions

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