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.

NCT07776821 | Recruiting Phase 4 DMC

• 1 other identifier: EC-2026-0094
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Uterine Cervical Neoplasms

Keywords

locally advanced carcinoma of the cervix

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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)

  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)

  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)

  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

  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

  From first dose of study drug to death from any cause; the 3-year OS rate will be assessed at 36 months.

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety ]

  From first dose of study drug to 30 days after the last dose, or until initiation of new anticancer therapy, whichever occurs first, assessed up to 3 years.

Study Arms (1)

Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother

EXPERIMENTAL

Drug: Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother

Interventions

Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother DRUG

Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother

Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin Cancer Hospital Airport Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (2)

Tianjin Cancer Hospital Airport Branch

Tianjin, 300060, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Liming Xu Liming Xu

CONTACT

18502255218; xuliming@tjmuch.com

Yaomei Ma

CONTACT

13702180627; mym905@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 20, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)