A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.

Eligibility criteria

Qualifiers

Female, aged 18-70 years (inclusive of cutoff values);

Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;

Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;

At least one measurable lesion according to RECIST v1.1;

Disqualifiers

Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);

He had undergone total hysterectomy (removal of the corpus uteri and cervix);

Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;

Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);

Trial design

Treatments tested in this trial

  • standard EBRT+Brachytherapy
  • Concurrent chemotherapy
  • Immune induction therapy
  • Reduced dose radiotherapy
  • Dose reduction concurrent chemotherapy
  • Immunomaintenance therapy

Treatment groups

378 Participants
are divided into 3 treatment groups