Cervical CancersPhase 2NCT06727617
Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
A Phase 2 study testing Serplulimab, Chemotherapy and radiotherapy in people with Cervical Cancers, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- Serplulimab, Chemotherapy and radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2024to 31 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
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, +86 13132032398, lychenying2004@126.com
About this study
Official title: Serplulimab Plus Chemoradiotherapy vs Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer Patients With Multiple Risk Factors: A Randomized, Open-Label, Phase II Clinical Trial
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
Read the detailed description
This study is a randomized, controlled, open-label, Phase II clinical trial designed to enroll patients with at least two risk factors (risk factors: lymph node metastasis, positive parametrial or resection margins, lymphovascular space invasion, or deep stromal invasion) following radical surgery for cervical cancer. The study aims to evaluate the efficacy and safety of Serplulimab in combination with chemoradiotherapy compared to chemoradiotherapy alone as adjuvant treatment. Patients must be deemed suitable for cisplatin or carboplatin plus nab-paclitaxel treatment as determined by the investigator. The choice between carboplatin and cisplatin will be based on the clinical judgment of the investigator. Eligible patients will be randomized in a 1:1 ratio to one of the following treatment arms: patients receiving Serplulimab plus chemoradiotherapy as adjuvant treatment (experimental group) or patients receiving chemoradiotherapy alone as adjuvant treatment (control group). The study is expected to enroll 67 patients in each group.
- Conditions
- Cervical Cancers
- Being tested
- Serplulimab, Chemotherapy, radiotherapy
- Keywords
- cervical cancer, high risk, immunotherapy, radiotherapy
- 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)
ChemotherapyDrug
Cisplatin: Administered by intravenous infusion during concurrent chemoradiotherapy at a dose of 30-40 mg/m² once weekly for only 5-6 treatment cycles; during sequential chemoradiotherapy, administered at 60-75 mg/m² on the first and second days of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles.
Paclitaxel: Nab-paclitaxel administered by intravenous infusion at a dose of 135-175 mg/m² on the first day of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles.
radiotherapyRadiation
Pelvic external beam radiation therapy at a dose of 1.8 Gy per fraction or 2 Gy per day, 5 times per week, with a total dose of 45-50 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab plus chemoradiotherapy group | Experimental | Serplulimab plus chemoradiotherapy group Receives: Drug: Serplulimab; Drug: Chemotherapy; Radiation: radiotherapy |
| chemoradiotherapy group | Placebo comparator | chemoradiotherapy group Receives: Drug: Chemotherapy; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
The time from the date of random assignment to the first occurrence of locoregional failure, DM, second primary tumor, or death from any cause.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
OS
The time from random assignment to death because of any cause.
Measured: through study completion, an average of 1 year
RFS
The time from random assignment to death because of any recurrence.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start19 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies 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
- 134 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maobin Meng, Dr., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727617
- Sponsor's protocol ID
- E20241188A
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2024
- Last updated
- 6 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serplulimab Plus Chemoradiotherapy vs Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer Patients With Multiple Risk Factors: A Randomized, Open-Label, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06727617
- Acronym / sponsor ID
- E20241188A
- Conditions
- Cervical Cancers
- Keywords
- cervical cancer, high risk, immunotherapy, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (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.
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
Detailed description
This study is a randomized, controlled, open-label, Phase II clinical trial designed to enroll patients with at least two risk factors (risk factors: lymph node metastasis, positive parametrial or resection margins, lymphovascular space invasion, or deep stromal invasion) following radical surgery for cervical cancer. The study aims to evaluate the efficacy and safety of Serplulimab in combination with chemoradiotherapy compared to chemoradiotherapy alone as adjuvant treatment. Patients must be deemed suitable for cisplatin or carboplatin plus nab-paclitaxel treatment as determined by the investigator. The choice between carboplatin and cisplatin will be based on the clinical judgment of the investigator. Eligible patients will be randomized in a 1:1 ratio to one of the following treatment arms: patients receiving Serplulimab plus chemoradiotherapy as adjuvant treatment (experimental group) or patients receiving chemoradiotherapy alone as adjuvant treatment (control group). The study is expected to enroll 67 patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serplulimab plus chemoradiotherapy group | Experimental | Drug: Serplulimab, Drug: Chemotherapy, Radiation: radiotherapySerplulimab plus chemoradiotherapy group |
| chemoradiotherapy group | Placebo comparator | Drug: Chemotherapy, Radiation: radiotherapychemoradiotherapy group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 | Serplulimab plus chemoradiotherapy group |
| ChemotherapyCisplatin: Administered by intravenous infusion during concurrent chemoradiotherapy at a dose of 30-40 mg/m² once weekly for only 5-6 treatment cycles; during sequential chemoradiotherapy, administered at 60-75 mg/m² on the first and second days of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles. Paclitaxel: Nab-paclitaxel administered by intravenous infusion at a dose of 135-175 mg/m² on the first day of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles. | Drug | Serplulimab plus chemoradiotherapy group, chemoradiotherapy group |
| radiotherapyPelvic external beam radiation therapy at a dose of 1.8 Gy per fraction or 2 Gy per day, 5 times per week, with a total dose of 45-50 Gy. | Radiation | Serplulimab plus chemoradiotherapy group, chemoradiotherapy group |
Primary outcome
DFS
Time frame: through study completion, an average of 1 year
The time from the date of random assignment to the first occurrence of locoregional failure, DM, second primary tumor, or death from any cause.
2 secondary outcomes
OS
Time frame: through study completion, an average of 1 year
RFS
Time frame: through study completion, an average of 1 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 6 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, Dr. 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, Chemotherapy and radiotherapy in people with Cervical Cancers, 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 11 inclusion and 9 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 6 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?
DFS (time frame: through study completion, an average of 1 year). 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 6 Jan 2026.