New drug combo aims to stop cervical cancer recurrence in high-risk patients
NCT ID NCT06727617
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the drug serplulimab to standard chemoradiotherapy after surgery can help prevent cervical cancer from returning in patients with multiple risk factors. About 134 women aged 18-65 with PD-L1 positive cervical cancer will be randomly assigned to receive either the drug combo or standard treatment alone. The goal is to see if the new approach improves how long patients stay cancer-free.
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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 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2026
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 65 years
- Sex
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Anyone
- 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: * Voluntarily participate in the clinical study: Fully understand and be informed about the study, and sign the informed consent form (ICF); willing to comply with and capable of completing all trial procedures. * Female aged ≥18 years and ≤65 years at the time of signing the ICF. * ECOG PS score of 0 or 1. * Positive PD-L1 status (CPS ≥1). * Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. * FIGO (International Federation of Gynecology and Obstetrics) stage of IB1, IB2, IIA1, or IIA2, and patients judged by the investigator to benefit from radical surgery and/or adjuvant therapy. * Have undergone radical hysterectomy (Piver classification) and pelvic lymphadenectomy of type II or III. * Postoperative pathological examination confirms at least two adverse factors, which may include: Lymph node metastasis; Positive parametrial or positive resection margins; Lymphovascular space invasion; Deep stromal invasion; * Patients must meet the following hematological, renal, and liver function criteria: Absolute neutrophil count of at least 1.5 × 10⁹/L; Platelet count of at least 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal; Creatinine levels not exceeding the upper limit of normal. * Female participants must have a negative serum pregnancy test within 14 days prior to treatment and agree to use effective contraception during the treatment period and for 6 months afterward; breastfeeding is prohibited during treatment. * Willing and able to comply with the trial and follow-up procedures. Exclusion Criteria: * Patients with unresectable residual tumors. * Histologically confirmed diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma. * Patients who have previously received pelvic radiotherapy. * History of other untreated malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ. * Presence of any active or known autoimmune disease. * History of inflammatory/autoimmune diseases requiring steroid treatment, or currently suffering from inflammatory/autoimmune diseases that require steroid treatment. * Diseases requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization. * History of thromboembolic events (venous or arterial) occurring within 6 months prior to enrollment. * Poorly controlled clinical symptoms or conditions related to heart disease.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood test may spot cervical cancer without a biopsy
- Can a higher radiation dose beat cervical cancer without more harm?
- Can adding radiation boost the power of immunotherapy in advanced cervical cancer?
- Can a Two-Pronged attack shrink Hard-to-Treat cancers?
- Could a condensed radiation course after cervical cancer surgery be just as safe and effective?
- Timing matters: early platelet booster may prevent dangerous drops in cervical cancer treatment