Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.

Eligibility criteria

Qualifiers

Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter >4 cm as assessed by contrast-enhanced pelvic MRI);

Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;

Female patients aged ≥18 and ≤75 years;

Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;

Disqualifiers

Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.

Clinically significant unrecoverable hydronephrosis;

CNS metastases or leptomeningeal disease;

Active malignancy within 3 years prior to enrollment (with specified exceptions);

Trial design

Treatments tested in this trial

  • Neoadjuvant Therapy Plus Surgery
  • Concurrent Chemoradiotherapy

Treatment groups

134 Participants
are divided into 2 treatment groups