Uterine Cervical NeoplasmsPhase 4NCT07776821
An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer.
A Phase 4 study testing Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother in people with Uterine Cervical Neoplasms, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
Trial summary
The objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2025to 1 Nov 2026
- Phase
- Phase 4
- 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
- Ages 18-75;
- Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma confirmed by histology or cytopathology;
- Patients with locally advanced cervical cancer who have not previously received any treatment and are classified as FIGO stage III-IV A as of 2018;
- ECOG performance status 0-1;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/dL, platelets (PLT) ≥ 100 × 10⁹/L;
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- Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); if liver metastases are present, ≤ 5×ULN; total bilirubin ≤ 1.5×ULN (this limit may be relaxed to 3×ULN for subjects with Gilbert's syndrome);
- Renal function: Serum creatinine (Cr) ≤ 1.5×ULN; if > 1.5×ULN, creatinine clearance must be ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);
- Coagulation: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN;
- According to the RECIST 1.1 criteria, the patient must have at least one evaluable lesion;
- Patients of childbearing potential must have a negative pregnancy test result and voluntarily use effective and reliable contraception during the study;
- Voluntarily participate in the study and sign an informed consent form.
Who cannot join
- A history of active malignant tumors within 3 years prior to the first dose, excluding cervical cancer, which is the subject of this trial, and any locally curable tumors that have already undergone curative treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured carcinoma in situ, such as ductal carcinoma in situ of the breast);
- Patients with active tuberculosis or a history of tuberculosis;
- Patients with a history of interstitial lung disease or non-infectious pneumonia requiring glucocorticoid therapy;
- Patients with hypertension that is not adequately controlled with antihypertensive medication (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
- Those who have experienced a serious cardiovascular event within 6 months prior to randomization, including but not limited to: stable angina classified as NYHA Class III-IV; unstable angina or myocardial infarction; NYHA Class III-IV congestive heart failure; severe arrhythmias requiring medication (asymptomatic atrial fibrillation is permitted if the ventricular rate can be controlled); Severe arterial or venous thromboembolic events (e.g., intracerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism);
- Patients with active autoimmune diseases, or a history of autoimmune diseases within the 2 years prior to randomization, who still require systemic treatment. However, subjects with the following conditions may be considered for further screening: well-controlled type 1 diabetes; hypothyroidism requiring only hormone replacement therapy and well-controlled; skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia); or subjects whose condition is not expected to recur in the absence of external triggers.
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- Individuals with a known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS);
- Subjects with uncontrolled pleural, pericardial, or abdominal/pelvic effusions requiring repeated drainage;
- Subjects who have received immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (prednisone >10 mg/day or other equivalent medications) within 2 weeks prior to receiving the study drug;
- Subjects who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 28 days prior to the first administration of the study drug, or who still have unhealed wounds, ulcers, or fractures at the time of screening;
- Subjects with a history of allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Subjects with other conditions deemed by the investigator to be incompatible with participation in this trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Tianjin Cancer Hospital Airport Branch
Tianjin, 300060
Liming Xu Liming Xu, 18502255218, xuliming@tjmuch.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Liming Xu Liming Xu, 18502255218, xuliming@tjmuch.com
Yaomei Ma, 13702180627, mym905@sina.com
About this study
The objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. The primary questions it aims to address are:
Can the Enlonstobart combination regimen improve the objective response rate and disease control rate in patients with locally advanced cervical cancer? What is the safety and tolerability profile of this combination regimen, and will any unexpected serious adverse events occur?
Read more
Participants will:
Receive induction therapy with Enlonstobart in combination with chemotherapy agents (e.g., paclitaxel plus platinum); Receive Enlonstobart in combination with concurrent chemoradiotherapy (external beam radiation therapy plus brachytherapy, with concurrent chemotherapy); Undergo regular tumor imaging evaluations (CT/MRI) and hematological safety assessments; Cooperate in completing efficacy assessments, adverse event documentation, and long-term follow-up.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother
- Keywords
- locally advanced carcinoma of the cervix
- 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.
Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiotherDrug
Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother
| Study group | Role | What they receive |
|---|---|---|
| Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother | Experimental | Not described Receives: Drug: Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: From first dose of study drug to documented disease progression, death, or study discontinuation for any reason, whichever occurs first, assessed up to 3 years
Secondary outcomes (5)
Progression-Free Survival(PFS)
Measured: From first dose of study drug to documented disease progression or death from any cause, whichever occurs first, assessed up to 3 years.
Disease Control Rate(DCR)
Measured: From first dose of study drug to documented disease progression, death, or study discontinuation for any reason, whichever occurs first, assessed up to 3 years.
Overall Survival(OS)
Measured: From first dose of study drug to death from any cause, or end of study/data cutoff, assessed up to 3 years.
3-year progression-free survival rate
Measured: From first dose of study drug to documented disease progression or death from any cause, whichever occurs first; the 3-year PFS rate will be assessed at 36 months.
3-year overall survival rate
Measured: From first dose of study drug to death from any cause; the 3-year OS rate will be assessed at 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Cancer Hospital Airport Hospital
- Responsible party
- Principal investigator, Liming Xu, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776821
- Sponsor's protocol ID
- EC-2026-0094
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer.
- ClinicalTrials.gov ID
- NCT07776821
- Acronym / sponsor ID
- EC-2026-0094
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- locally advanced carcinoma of the cervix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Tianjin Cancer Hospital Airport Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 20 Aug 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.
The objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. The primary questions it aims to address are:
Can the Enlonstobart combination regimen improve the objective response rate and disease control rate in patients with locally advanced cervical cancer? What is the safety and tolerability profile of this combination regimen, and will any unexpected serious adverse events occur?
Participants will:
Receive induction therapy with Enlonstobart in combination with chemotherapy agents (e.g., paclitaxel plus platinum); Receive Enlonstobart in combination with concurrent chemoradiotherapy (external beam radiation therapy plus brachytherapy, with concurrent chemotherapy); Undergo regular tumor imaging evaluations (CT/MRI) and hematological safety assessments; Cooperate in completing efficacy assessments, adverse event documentation, and long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother | Experimental | Drug: Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ages 18-75;
- Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma confirmed by histology or cytopathology;
- Patients with locally advanced cervical cancer who have not previously received any treatment and are classified as FIGO stage III-IV A as of 2018;
- ECOG performance status 0-1;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
Key exclusion criteria (12 listed)
- A history of active malignant tumors within 3 years prior to the first dose, excluding cervical cancer, which is the subject of this trial, and any locally curable tumors that have already undergone curative treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured carcinoma in situ, such as ductal carcinoma in situ of the breast);
- Patients with active tuberculosis or a history of tuberculosis;
- Patients with a history of interstitial lung disease or non-infectious pneumonia requiring glucocorticoid therapy;
- Patients with hypertension that is not adequately controlled with antihypertensive medication (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
- Those who have experienced a serious cardiovascular event within 6 months prior to randomization, including but not limited to: stable angina classified as NYHA Class III-IV; unstable angina or myocardial infarction; NYHA Class III-IV congestive heart failure; severe arrhythmias requiring medication (asymptomatic atrial fibrillation is permitted if the ventricular rate can be controlled); Severe arterial or venous thromboembolic events (e.g., intracerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism);
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 combined with chemotherapy for induction therapy followed by concurrent radiotherEnlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother | Drug | Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother |
Primary outcome
Objective Response Rate (ORR)
Time frame: From first dose of study drug to documented disease progression, death, or study discontinuation for any reason, whichever occurs first, assessed up to 3 years
5 secondary outcomes
Progression-Free Survival(PFS)
Time frame: From first dose of study drug to documented disease progression or death from any cause, whichever occurs first, assessed up to 3 years.
Disease Control Rate(DCR)
Time frame: From first dose of study drug to documented disease progression, death, or study discontinuation for any reason, whichever occurs first, assessed up to 3 years.
Overall Survival(OS)
Time frame: From first dose of study drug to death from any cause, or end of study/data cutoff, assessed up to 3 years.
3-year progression-free survival rate
Time frame: From first dose of study drug to documented disease progression or death from any cause, whichever occurs first; the 3-year PFS rate will be assessed at 36 months.
3-year overall survival rate
Time frame: From first dose of study drug to death from any cause; the 3-year OS rate will be assessed at 36 months.
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 25 Aug 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother in people with Uterine Cervical Neoplasms, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites 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 12 inclusion and 12 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Liming Xu Liming Xu (18502255218, xuliming@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From first dose of study drug to documented disease progression, death, or study discontinuation for any reason, whichever occurs first, assessed up to 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 25 Aug 2026.