Health Trials

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.

ConditionUterine Cervical Neoplasms
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

    Drug

    Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiotherExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety ]

Use CTC AE v5.0 to grade adverse events (AE)

Time frame
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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Tianjin Cancer Hospital Airport Hospital

Collaborator

Source ClinicalTrials.gov
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