Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorChongqing University Cancer Hospital

About this trial

This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.

Eligibility criteria

Qualifiers

The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;

Female aged 18-75 years (at the time of signing the informed consent);

ECOG score of 0-1 within 7 days prior to first study intervention dose;

Expectation of life ≥ 12 weeks;

Disqualifiers

Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;

Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;

Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE 5.0]);

Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);

Trial design

Treatments tested in this trial

  • Envafolimab
  • Cisplatin
  • External Beam Radiotherapy (EBRT)
  • Brachytherapy (BT)

Treatment groups

36 Participants
are divided into 1 treatment group