Cervical CancerPhase 2NCT06128460
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
A Phase 2 study testing Zimberelimab, Platinum and radiotherapy in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University.
Trial summary
Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Zimberelimab, Platinum and radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2029
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;
- According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;
- Patients with radical surgery for cervical cancer;
- Female patients: 18-70 years old;
- ECOG physical condition score: 0~1 point;
- Subjects have not received previous immunotherapy;
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- Expected survival ≥6 months;
- Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient;
- For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy
- Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- Subjects have histological subtypes other than those permitted by inclusion criteria;
- Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);
- Participate in or have participated in other clinical trials within 4 weeks before enrollment;
- Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;
- Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;
- Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose;
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- Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs);
- Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;
- An active infection requiring systematic treatment;
- Known history of HIV infection;
- A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA[qualitative]) infection;
- Known active tuberculosis (TB; Tuberculosis) medical history;
- Has received allogeneic tissue/solid organ transplantation;
- Suffering from central nervous system metastases such as brain metastases;
- Patients with uncontrolled chest and abdominal fluid;
- Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;
- Insufficient hematopoietic function of bone marrow;
- Abnormal liver;
- Abnormal kidney;
- Bleeding risk;
- Cardiovascular and cerebrovascular abnormalities.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients
Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.
Read the detailed description
For cervical cancer, although clinical research on PD-1 monoclonal antibodies was launched relatively late, the research results so far show that PD-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced/recurrent cervical cancer. Good security. However, there is currently a lack of clinical evidence for the use of PD-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. Therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by PD-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (IB3, IIA2) cervical cancer after surgery, and provide a new solution for clinical treatment.
- Conditions
- Cervical Cancer
- Being tested
- Zimberelimab, Platinum, 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.
ZimberelimabDrug
240mg, q3w，8 cycles
PlatinumDrug
cisplatin 40mg/m2 for 5-6 cycles
radiotherapyRadiation
45-50Gy/1.8Gy/25-28f
| Study group | Role | What they receive |
|---|---|---|
| Concurrent themoradiotherapy Followed by Zimberelimab | Experimental | 1. Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f.
2. Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times;
3. Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles Receives: Drug: Zimberelimab; Drug: Platinum; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in tumor-related biomarkers
changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)
Measured: 3 years
Secondary outcomes (3)
OS
Overall Survival
Measured: 5 years
DFS
Disease Free Survival
Measured: 2 years
AE
Adverse event
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2029 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keqin Hua, Obstetrics & Gynecology Hospital of Fudan University
- Investigators
- Keqin Hua, Doctor, Principal investigator, Gynecology and obstetrics hospital of fudan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128460
- Sponsor's protocol ID
- GLS-010-672
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients
- ClinicalTrials.gov ID
- NCT06128460
- Acronym / sponsor ID
- GLS-010-672
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 13 Nov 2023 (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.
Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.
Detailed description
For cervical cancer, although clinical research on PD-1 monoclonal antibodies was launched relatively late, the research results so far show that PD-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced/recurrent cervical cancer. Good security. However, there is currently a lack of clinical evidence for the use of PD-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. Therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by PD-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (IB3, IIA2) cervical cancer after surgery, and provide a new solution for clinical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent themoradiotherapy Followed by Zimberelimab | Experimental | Drug: Zimberelimab, Drug: Platinum, Radiation: radiotherapy1. Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f. 2. Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times; 3. Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;
- According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;
- Patients with radical surgery for cervical cancer;
- Female patients: 18-70 years old;
- ECOG physical condition score: 0~1 point;
Key exclusion criteria (21 listed)
- Subjects have histological subtypes other than those permitted by inclusion criteria;
- Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);
- Participate in or have participated in other clinical trials within 4 weeks before enrollment;
- Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;
- Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;
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 |
|---|---|---|
| Zimberelimab240mg, q3w，8 cycles | Drug | Concurrent themoradiotherapy Followed by Zimberelimab |
| Platinumcisplatin 40mg/m2 for 5-6 cycles | Drug | Concurrent themoradiotherapy Followed by Zimberelimab |
| radiotherapy45-50Gy/1.8Gy/25-28f | Radiation | Concurrent themoradiotherapy Followed by Zimberelimab |
Primary outcome
changes in tumor-related biomarkers
Time frame: 3 years
changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)
3 secondary outcomes
OS
Time frame: 5 years
DFS
Time frame: 2 years
AE
Time frame: 3 years
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 30 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Keqin Hua, Doctor principal investigator
Gynecology and obstetrics hospital of fudan university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zimberelimab, Platinum and radiotherapy in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University.
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 21 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: opening soon, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Junjun Qiu, Doctor (18017738139, qiujunjun1113@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in tumor-related biomarkers (time frame: 3 years). 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 30 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.