Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer

Browse trials for

• Uterine Cervical Neoplasms 1,881

Keywords

• Local advanced cervical cancer
• Concurrent chemoradiotherapy

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 33 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Lead sponsor

Chongqing University Cancer Hospital is the lead sponsor of 40 studies on the registry; 27 are open to participants now.

Study arms

• Experimental
  treatment arm

  Participants receive Cadonilimab at a dose of 10 mg/kg, Q3W (Day 1 of each 21 day treatment cycle) via IV infusion, until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraw informed consent, or Cadonilimab treatment over 2 years. During the q3w dosing period of Cadonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy.

  Drug: Cadonilimab（AK104） · Radiation: EBRT · Radiation: BT

Interventions

• DrugCadonilimab（AK104）

  q3w iv

• RadiationEBRT

  45-50.4Gy

• RadiationBT

  ≥80Gy

Primary outcomes

1. ORR assessed by Investigator

   The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.

   Time frame: Up to 2 years

Secondary outcomes

1. DCR

   The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

   Time frame: Up to 2 years

2. PFS

   Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

   Time frame: Up to approximately 30 months

3. OS

   OS is the time from randomization to death due to any cause

   Time frame: Up to approximately 40 months

4. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score and Physical Function Score.

   The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.

   Time frame: Baseline and up to approximately 40 months

5. Number of participants with adverse events (AEs)

   An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

   Time frame: Up to approximately 40 months

Individual participant data

Plan to share: No