LOCALLY ADVANCED CERVICAL CANCERSPhase 2NCT06981858
A Single-Arm Exploratory Study of Enlansibumab Sequentially Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
A Phase 2 study testing Enlonstobart Injection in people with LOCALLY ADVANCED CERVICAL CANCERS, run by Chongqing University Cancer Hospital.
Trial summary
This is a prospective , single - arm clinical study , aiming to evaluate the efficacy and safety of Enlansibumab sequential concurrent chemoradiotherapy in locally advanced cervical cancer. Patients will first receive one cycle of Enlansibumab monotherapy (360 mg, 60 - min IV infusion on day 1, every 3 weeks). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- LOCALLY ADVANCED CERVICAL CANCERS
- What is being tested?
- Enlonstobart Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 1 Feb 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
- Female, aged 18-70 years (including boundary values);
- Diagnosed histologically as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 3.2018 FIGO stage IIB-IVA; Assess lymph node involvement based on one of the following criteria:
- Lymph node involvement confirmed by histology and biopsy;
- MRI or CT shows one or more positive pelvic/abdominal aortic lymph nodes with a minimum diameter of ≥ 15mm;
- PET/CT or PET/MR display one or more positive pelvic/abdominal aortic lymph nodes with SUVmax ≥ 2.5 and higher than the background value in surrounding normal tissues.
- According to the evaluation criteria for solid tumor efficacy version 1.1 (RECIST v1.1), having at least one measurable lesion; 5.ECOG PS 0-1； 6. According to the researcher's judgment, those with an expected survival period of ≥ 3 months; 7. The subjects can provide tumor tissue sections to determine whether formalin fixed paraffin embedded tumor histopathological samples or fresh tumor histopathological samples can be used for PD-L1 expression and other immune indicators detection; 8. Have sufficient organ function and meet the following laboratory examination standards:
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- Blood routine (no blood transfusion within 14 days, no use of hematopoietic stimulating factors, and no use of other drugs to correct blood cell count): White blood cell count (WBC) ≥ 3000/mm3; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (HGB) ≥ 9g/dL;
- Blood biochemistry: creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), if>1.5 × ULN, creatinine clearance rate must be ≥ 60mL/min, calculated using the Cockcroft Gault formula; Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- Thyroid function: Thyroid stimulating hormone (TSH) ≤ ULN; If there are abnormalities, additional tests should be conducted on T3 and T4, and their levels should be normal; 9. Women of childbearing age who have a negative pregnancy test and are not breastfeeding, and have fertility, must receive effective medical contraception measures (from signing the informed consent form to within 6 months after the last study administration); 10. Participants must agree to collect blood samples, paraffin embedded (FFPE) tumor tissue specimens or sections, and fresh tumor tissue specimens for relevant research.
- 11. The subjects voluntarily participated in this study, had good compliance with the planned treatment and follow-up, understood the research process of this study, and voluntarily signed an informed consent form.
Who cannot join
- There are distant metastatic diseases present;
- Have received any previous anti-tumor treatment, including but not limited to surgery (excluding biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
- Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies;
- Active malignant tumor within 3 years before the first administration, excluding cervical cancer studied in this trial and any locally curable tumor that has received radical treatment (such as excised basal cell or squamous cell skin cancer, superficial bladder cancer cancer or cured carcinoma in situ, such as breast carcinoma in situ);
- Suffering from active autoimmune diseases, or having a history of autoimmune diseases within 2 years before enrollment, and still requiring systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators;
- Suffering from primary immunodeficiency disease or having a medical history;
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- Individuals who have received immunosuppressive therapy (such as cyclosporine) or require systemic steroid therapy (such as>20 mg/day prednisone or equivalent) within the 14 days prior to enrollment, except for those who receive local corticosteroid therapy via nasal spray, inhalation, or other routes;
- Individuals who are HIV Ab positive or have active syphilis infection; Hepatitis B virus surface antigen (HBsAg) is positive, and the detection value of hepatitis B virus is>500IU/ml or 2500 copies/mL; Hepatitis C antibody (HCV Ab) is positive, and the hepatitis C virus RNA quantification is greater than the upper limit of the normal value of the detection unit. (Note: For those with positive hepatitis B virus surface antigen (HBsAg), antiviral treatment is recommended before the first use of the study drug, and nucleoside analogs such as entecavir and tenofovir dipivoxil are recommended. )
- Active bacterial, fungal, or viral infections (defined as requiring intravenous injection of antibacterial, antifungal, or antiviral drugs for treatment) within 14 days prior to enrollment. For individuals who have no clinical manifestations of active infection before the first medication and receive prophylactic treatment for infection, they may be considered for inclusion;
- Active tuberculosis or medical history;
- Have experienced severe cardiovascular disease within the 6 months prior to enrollment, including but not limited to: stable angina pectoris with functional classification of III-IV; Unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; Severe arrhythmia requiring medication treatment (if ventricular rate can be controlled, asymptomatic atrial fibrillation subjects are allowed to be included); Serious arterial/venous thrombotic events (such as cerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism);
- Suffering from uncontrollable hypertension;
- Have previously suffered from interstitial lung disease or non infectious pneumonia requiring glucocorticoid treatment;
- There is clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stent placement, as determined by researchers; Within 28 days prior to enrollment or planned to receive live or attenuated vaccine treatment during the study period;
- 16. Known recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Have a history of severe allergic reactions and uncontrolled allergic asthma to all components of monoclonal antibody preparations; 18. There are contraindications or severe allergic reactions to any component of cisplatin; 19. Individuals who have participated in other clinical trials and used the investigational drug within 28 days prior to enrollment; 20. Participants who may have poor compliance with the research procedures and requirements, as determined by the researchers, such as those with a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current mental disorders, and substance abuse; 21. Individuals with a clear history of neurological or mental disorders or drug abuse who are unable to quit or have a history of drug use; 22. There are situations where other researchers have determined that it is not suitable to participate in this experiment.
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
This is a prospective , single - arm clinical study , aiming to evaluate the efficacy and safety of Enlansibumab sequential concurrent chemoradiotherapy in locally advanced cervical cancer. Patients will first receive one cycle of Enlansibumab monotherapy (360 mg, 60 - min IV infusion on day 1, every 3 weeks). After one treatment cycle (3 weeks), they'll undergo imaging assessment. Then, they'll have Enlansibumab (360 mg, 60 - min IV infusion on day 1, every 3 weeks for two cycles) combined with concurrent chemoradiotherapy. Chemotherapy involves cisplatin (40 mg/m²) or carboplatin (AUC2) via IV infusion, weekly (±7 days), with five planned cycles. Investigators may add a sixth platinum - based chemotherapy cycle if needed. Radiotherapy comprises EBRT and BT and must be completed within eight weeks of treatment initiation. The total prescription dose of EBRT combined with BT should have an EQD2 of ≥8000 cGy, with adjustments based on tumor regression. After concurrent chemoradiotherapy, treatment ends. An imaging assessment occurs around seven days (±3 days) later. Then, the follow - up phase begins, including final, safety, and survival follow - ups, continuing until patients are lost to follow-up, the follow-up ends, or they die.
- Conditions
- LOCALLY ADVANCED CERVICAL CANCERS
- Being tested
- Enlonstobart Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlonstobart InjectionDrug
Sequential Enlonstobart Injection with concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Sequential Enlonstobart Injection with concurrent chemoradiotherapy | Experimental | Not described Receives: Drug: Enlonstobart Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year PFS rate
Measured: 1 year after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start15 May 2025 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LOCALLY ADVANCED CERVICAL CANCERSStudies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981858
- Sponsor's protocol ID
- CZLS2025107-A
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Exploratory Study of Enlansibumab Sequentially Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT06981858
- Acronym / sponsor ID
- CZLS2025107-A
- Conditions
- LOCALLY ADVANCED CERVICAL CANCERS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 21 May 2025 (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 is a prospective , single - arm clinical study , aiming to evaluate the efficacy and safety of Enlansibumab sequential concurrent chemoradiotherapy in locally advanced cervical cancer. Patients will first receive one cycle of Enlansibumab monotherapy (360 mg, 60 - min IV infusion on day 1, every 3 weeks). After one treatment cycle (3 weeks), they'll undergo imaging assessment. Then, they'll have Enlansibumab (360 mg, 60 - min IV infusion on day 1, every 3 weeks for two cycles) combined with concurrent chemoradiotherapy. Chemotherapy involves cisplatin (40 mg/m²) or carboplatin (AUC2) via IV infusion, weekly (±7 days), with five planned cycles. Investigators may add a sixth platinum - based chemotherapy cycle if needed. Radiotherapy comprises EBRT and BT and must be completed within eight weeks of treatment initiation. The total prescription dose of EBRT combined with BT should have an EQD2 of ≥8000 cGy, with adjustments based on tumor regression. After concurrent chemoradiotherapy, treatment ends. An imaging assessment occurs around seven days (±3 days) later. Then, the follow - up phase begins, including final, safety, and survival follow - ups, continuing until patients are lost to follow-up, the follow-up ends, or they die.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential Enlonstobart Injection with concurrent chemoradiotherapy | Experimental | Drug: Enlonstobart Injection |
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)
- Female, aged 18-70 years (including boundary values);
- Diagnosed histologically as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 3.2018 FIGO stage IIB-IVA; Assess lymph node involvement based on one of the following criteria:
- According to the evaluation criteria for solid tumor efficacy version 1.1 (RECIST v1.1), having at least one measurable lesion; 5.ECOG PS 0-1； 6. According to the researcher's judgment, those with an expected survival period of ≥ 3 months; 7. The subjects can provide tumor tissue sections to determine whether formalin fixed paraffin embedded tumor histopathological samples or fresh tumor histopathological samples can be used for PD-L1 expression and other immune indicators detection; 8. Have sufficient organ function and meet the following laboratory examination standards:
- Blood routine (no blood transfusion within 14 days, no use of hematopoietic stimulating factors, and no use of other drugs to correct blood cell count): White blood cell count (WBC) ≥ 3000/mm3; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (HGB) ≥ 9g/dL;
- Blood biochemistry: creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), if>1.5 × ULN, creatinine clearance rate must be ≥ 60mL/min, calculated using the Cockcroft Gault formula; Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
Key exclusion criteria (15 listed)
- There are distant metastatic diseases present;
- Have received any previous anti-tumor treatment, including but not limited to surgery (excluding biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
- Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies;
- Active malignant tumor within 3 years before the first administration, excluding cervical cancer studied in this trial and any locally curable tumor that has received radical treatment (such as excised basal cell or squamous cell skin cancer, superficial bladder cancer cancer or cured carcinoma in situ, such as breast carcinoma in situ);
- Suffering from active autoimmune diseases, or having a history of autoimmune diseases within 2 years before enrollment, and still requiring systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators;
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 |
|---|---|---|
| Enlonstobart InjectionSequential Enlonstobart Injection with concurrent chemoradiotherapy | Drug | Sequential Enlonstobart Injection with concurrent chemoradiotherapy |
Primary outcome
1-year PFS rate
Time frame: 1 year after treatment initiation
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 21 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enlonstobart Injection in people with LOCALLY ADVANCED CERVICAL CANCERS, run by Chongqing University Cancer Hospital.
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 15 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 21 May 2025. 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 Dongling Zou (13657690699, 13570049@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year PFS rate (time frame: 1 year after treatment initiation). 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 21 May 2025.