Immunotherapy before surgery could boost cervical cancer outcomes

NCT ID NCT07088731

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 2 trial compares two approaches for locally advanced cervical cancer: standard chemoradiotherapy versus a newer strategy of chemotherapy plus immunotherapy (sintilimab) before surgery. The study will enroll 180 people and track how long they live without the cancer getting worse over two years. The goal is to see if adding immunotherapy before surgery improves results compared to the current standard treatment.

What this could mean

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

Active substance
Nab-paclitaxel, cisplatin, and sintilimab (a type of immunotherapy)
What this could lead to
If successful, this could show that adding immunotherapy before surgery improves outcomes for locally advanced cervical cancer, potentially offering a new treatment option.
What could go wrong
This is a Phase 2 trial, so results are still early and may not confirm benefit. Adding immunotherapy can cause immune-related side effects, and the study is small and single-center, limiting generalizability.

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 180 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jul 2027

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: * Aged ≥ 18 years and ≤ 70 years; * Cervical cancer with pathological types being squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; * Staged IB3 or IIA2 according to the FIGO 2018 staging system, as assessed by the investigator; * ECOG performance status of 0-2, or KPS score ≥ 70; * Expected survival time of more than 3 months; * Having at least one measurable lesion in accordance with RECIST 1.1; * Laboratory test results meeting the following criteria without drug intervention: 1. Hemoglobin ≥ 90 g/dl, neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L; 2. Creatinine ≤ 1.5 times the upper limit of normal range; 3. Total bilirubin, alanine transaminase (ALT), and aspartate transaminase (AST) \< 2 times the upper limit of normal; * Postmenopausal, or reproductive-aged women who meet all the following conditions: non-lactating, not pregnant, and able to use effective contraceptive measures during the study treatment period; * Voluntarily participating in this study and signing the informed consent form. Exclusion Criteria: * Participated in other clinical trials within 30 days before receiving the first dose of chemotherapy drugs or during the treatment period. * Previously received any other anti-tumor treatment for cervical cancer. * Non-HPV-related cervical cancer. * Needing to receive other anti-tumor treatments during the study treatment period. * Patients with known allergies to the active ingredients of the study drugs or their excipients. * Diagnosed with other malignant tumors in the past 5 years (except those judged to be cured by the investigator). * Active infections requiring systemic treatment. * Positive for human immunodeficiency virus (HIV) antibody. * Positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody. * Peripheral neuropathy with a grade of ≥ 2 according to the NCI-CTCAE (Version 5.0). * Concurrent diseases or abnormal test results that interfere with the subject's ability to receive anti-tumor treatment as judged by the investigator, such as the estimated inability of the subject to tolerate at least 2 cycles of neoadjuvant chemotherapy plus surgery or concurrent chemoradiotherapy, etc. Participation in this study is deemed not conducive to the maximum benefit of the subject as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma 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

  • Department of Gynecological Oncology

    Beijing, China

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