Immunotherapy before surgery could boost cervical cancer outcomes
NCT ID NCT07088731
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cervical carcinoma are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fewer, stronger radiation doses spare the bowel in gynecologic cancers?
- A chill pill for Chemo's side effects? cooling therapy and a Blood-Flow drug take on nerve pain
- Could a simple Self-Swab revolutionize cervical cancer screening?
- Could vitamin d predict cervical cancer treatment success?
- Can a triple-threat approach wipe out cervical cancer before surgery?
- Particle beam and immune therapy join forces against cervical cancer