Cervical CancerPhase 2NCT07340489
Serplulimab for Locally Advanced Cervical Cancer
A Phase 2 study testing Serplulimab, radiotherapy and Chemotherapy in people with Cervical Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Serplulimab, radiotherapy and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2025to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF);
- Willing and able to comply with all study procedures;
- Female aged 18-75 years;
- ECOG performance status of 0 or 1;
- PD-L1 status not restricted;
- Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
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- FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA;
- Patients must meet the following hematologic, renal, and hepatic function criteria:
- 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;
- 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.
Who cannot join
- Histologically confirmed small cell cervical cancer;
- Recurrent cervical cancer or presence of distant metastases;
- Prior anti-tumor treatment;
- 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;
- Any active or known autoimmune disease;
- Active infection;
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- Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization;
- Arterial or venous thromboembolic events within 6 months prior to enrollment;
- Uncontrolled clinically significant cardiac symptoms or disease;
- Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies;
- Pregnant or breastfeeding women;
- Neurological or psychiatric abnormalities affecting cognitive function;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital,
Tianjin, Tianjin Municipality, 300060
Maobin Meng, Dr., +86 15202231270, mmeng@tmu.edu.cn
Ying Chen, Dr., +86 13132032398, lychenying2004@126.com
About this study
Official title: Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial
This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. The primary endpoint of this study is progression-free survival (PFS).
Read the detailed description
This study is a randomized, controlled, open-label, phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy and concurrent chemoradiotherapy in patients with locally advanced cervical cancer. Eligible patients are women aged 18-75 years with FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB disease with lymph node positivity or stage III-IVA disease. Patients will be randomly assigned to two groups. Patients in the control group will receive serplulimab immunotherapy combined with concurrent chemoradiotherapy, followed by maintenance serplulimab for up to 2 years. Patients in the experimental group will receive, in addition to the above treatment, two cycles of induction chemotherapy and four cycles of consolidation chemotherapy, consisting of paclitaxel and platinum-based agents. The primary endpoint of this study is progression-free survival (PFS), which will be assessed by investigators according to RECIST version 1.1.
- Conditions
- Cervical Cancer
- Being tested
- Serplulimab, radiotherapy, Chemotherapy
- Keywords
- cervical cancer, immunotherapy, chemoradiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
intravenous infusion of 300 mg, administered every 3 weeks as one cycle, on the first day of each cycle, with a maximum treatment duration of 2 years (up to 35 treatment cycles)
radiotherapyRadiation
Pelvic external beam radiotherapy was delivered with a prescribed dose of 45.0-50.4 Gy in 25-28 fractions to the PTV, administered once daily, five days per week; the PGTVnd received a simultaneous integrated boost to 53.50-59.92 Gy in 25-28 fractions. During radiotherapy, concurrent chemotherapy with weekly cisplatin was administered.
Brachytherapy was delivered with 28 Gy in 4 fractions, prescribed to the 100% isodose line covering the CTV.
ChemotherapyDrug
Two cycles of induction chemotherapy were administered prior to concurrent chemoradiotherapy, consisting of cisplatin 60-75 mg/m² on days 1 and 2 of each cycle, once every 3 weeks (21 days), and nab-paclitaxel 135-175 mg/m² by intravenous infusion on day 1 of each cycle, once every 3 weeks (21 days). After completion of concurrent chemoradiotherapy, patients received four cycles of consolidation chemotherapy using the same cisplatin and nab-paclitaxel regimen as above.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: chemotherapy combined with immunotherapy and radiotherapy | Experimental | chemotherapy an Serplulimab plus chemoradiotherapy group Receives: Drug: Serplulimab; Radiation: radiotherapy; Drug: Chemotherapy |
| Control group: immunotherapy and radiotherapy | Placebo comparator | Serplulimab plus chemoradiotherapy group Receives: Drug: Serplulimab; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
defined as the time from randomization to the first occurrence of disease progression or death from any cause.
Measured: through study completion, an average of 2 year
OS
The time from random assignment to death because of any cause.
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
safety assessment
Adverse events occurring throughout the study period will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start3 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maobin Meng, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340489
- Sponsor's protocol ID
- E20251312
- Status last verified
- Dec 2025
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07340489
- Acronym / sponsor ID
- E20251312
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, immunotherapy, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. The primary endpoint of this study is progression-free survival (PFS).
Detailed description
This study is a randomized, controlled, open-label, phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy and concurrent chemoradiotherapy in patients with locally advanced cervical cancer. Eligible patients are women aged 18-75 years with FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB disease with lymph node positivity or stage III-IVA disease. Patients will be randomly assigned to two groups. Patients in the control group will receive serplulimab immunotherapy combined with concurrent chemoradiotherapy, followed by maintenance serplulimab for up to 2 years. Patients in the experimental group will receive, in addition to the above treatment, two cycles of induction chemotherapy and four cycles of consolidation chemotherapy, consisting of paclitaxel and platinum-based agents. The primary endpoint of this study is progression-free survival (PFS), which will be assessed by investigators according to RECIST version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: chemotherapy combined with immunotherapy and radiotherapy | Experimental | Drug: Serplulimab, Radiation: radiotherapy, Drug: Chemotherapychemotherapy an Serplulimab plus chemoradiotherapy group |
| Control group: immunotherapy and radiotherapy | Placebo comparator | Drug: Serplulimab, Radiation: radiotherapySerplulimab plus chemoradiotherapy group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF);
- Willing and able to comply with all study procedures;
- Female aged 18-75 years;
- ECOG performance status of 0 or 1;
- PD-L1 status not restricted;
Key exclusion criteria (13 listed)
- Histologically confirmed small cell cervical cancer;
- Recurrent cervical cancer or presence of distant metastases;
- Prior anti-tumor treatment;
- 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;
- Any active or known autoimmune disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serplulimabintravenous infusion of 300 mg, administered every 3 weeks as one cycle, on the first day of each cycle, with a maximum treatment duration of 2 years (up to 35 treatment cycles) | Drug | Control group: immunotherapy and radiotherapy, Experimental: chemotherapy combined with immunotherapy and radiotherapy |
| radiotherapyPelvic external beam radiotherapy was delivered with a prescribed dose of 45.0-50.4 Gy in 25-28 fractions to the PTV, administered once daily, five days per week; the PGTVnd received a simultaneous integrated boost to 53.50-59.92 Gy in 25-28 fractions. During radiotherapy, concurrent chemotherapy with weekly cisplatin was administered. Brachytherapy was delivered with 28 Gy in 4 fractions, prescribed to the 100% isodose line covering the CTV. | Radiation | Control group: immunotherapy and radiotherapy, Experimental: chemotherapy combined with immunotherapy and radiotherapy |
| ChemotherapyTwo cycles of induction chemotherapy were administered prior to concurrent chemoradiotherapy, consisting of cisplatin 60-75 mg/m² on days 1 and 2 of each cycle, once every 3 weeks (21 days), and nab-paclitaxel 135-175 mg/m² by intravenous infusion on day 1 of each cycle, once every 3 weeks (21 days). After completion of concurrent chemoradiotherapy, patients received four cycles of consolidation chemotherapy using the same cisplatin and nab-paclitaxel regimen as above. | Drug | Experimental: chemotherapy combined with immunotherapy and radiotherapy |
Primary outcome
PFS
Time frame: through study completion, an average of 2 year
defined as the time from randomization to the first occurrence of disease progression or death from any cause.
OS
Time frame: through study completion, an average of 2 year
The time from random assignment to death because of any cause.
1 secondary outcome
safety assessment
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maobin Meng principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, radiotherapy and Chemotherapy in people with Cervical Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maobin Meng, Dr. (+86 15202231270, mmeng@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.