Immunotherapy combo aims to stop cervical cancer in its tracks
NCT ID NCT07340489
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether adding the immunotherapy drug serplulimab to standard chemoradiotherapy can help people with locally advanced cervical cancer live longer without their disease getting worse. About 216 participants who have not yet been treated will receive either chemoradiotherapy alone or with serplulimab. The study will track how long it takes for the cancer to progress and monitor any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- serplulimab (an immunotherapy drug) plus standard chemoradiotherapy (radiation and chemotherapy)
- What this could lead to
- If it works, this could lead to a new treatment option that helps keep cervical cancer from growing or coming back for longer.
- What could go wrong
- This is an early phase II trial with only 216 participants, so results may not apply to everyone. Immunotherapy can cause side effects like inflammation in healthy organs.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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: 1. Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF); 2. Willing and able to comply with all study procedures; 3. Female aged 18-75 years; 4. ECOG performance status of 0 or 1; 5. PD-L1 status not restricted; 6. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 7. FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA; 8. Patients must meet the following hematologic, renal, and hepatic function criteria: 9. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); Serum creatinine ≤ upper limit of normal (ULN); No prior anti-tumor treatment; Expected survival \> 6 months; 10. Female subjects must have a negative serum pregnancy test within 14 days prior to study treatment, agree to use effective contraception during treatment and for 6 months after treatment, and breastfeeding is prohibited during the study. Exclusion Criteria: 1. Histologically confirmed small cell cervical cancer; 2. Recurrent cervical cancer or presence of distant metastases; 3. Prior anti-tumor treatment; 4. Current or history of another active, untreated malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ; 5. Any active or known autoimmune disease; 6. Active infection; 7. Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization; 8. Arterial or venous thromboembolic events within 6 months prior to enrollment; 9. Uncontrolled clinically significant cardiac symptoms or disease; 10. Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies; 11. Pregnant or breastfeeding women; 12. Neurological or psychiatric abnormalities affecting cognitive function; 13. Any other condition or situation that, in the investigator's judgment, would pose a serious risk to the subject's safety, potentially confound study results, or interfere with the subject's ability to complete the study.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tianjin Medical University Cancer Institute & Hospital,
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Other studies related to the condition(s) this trial covers.
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