A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab(AK104) for Newly Diagnosed Local Advanced Cervical Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWest China Second University Hospital

About this trial

This study will evaluate the efficacy and safety of concurrent chemoradiotherapy(CCRT)followed by cadonilimab(AK104) in high risk local advanced cervical cancer.

Participants received CCRT,efficacy evaluation of CCRT was no disease progression who maintained with AK104(10.0 mg/kg,Q3W)until drug exposure over 1 years or disease progression or intolerable toxicity.

Eligibility criteria

Qualifiers

Voluntary agreement to provide written informed consent.

female, Age 18 -75 years.

Predicted survival ≥ 3 month.

Histologically and/or cytologically confirmed Squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, FIGO 2018 stage III-IVA.

Disqualifiers

Has received other antitumor therapy before CCRT.

Therapeutic evaluation of CCRT was disease progression.

Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any tumor immune mechanisms treatment .

With brain metastases.

Trial design

Treatments tested in this trial

  • AK104

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

West China Second University Hospital

Lead sponsor

Affiliated Hospital of North Sichuan Medical College

Collaborator

The Affiliated Hospital Of Southwest Medical University

Collaborator