RecruitingPhase 3NCT07400536

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

A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

378 participants

Start Date

Apr 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • To be enrolled, subjects had to meet all of the following criteria:
  • 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;
  • Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
  • Have adequate organ function.

Exclusion Criteria6

  • Subjects were excluded from the study if they met any of the following criteria:
  • 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);
  • Had any condition that was deemed by other investigators to be ineligible for participation in the trial.

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Interventions

RADIATIONstandard EBRT+Brachytherapy

EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5

DRUGConcurrent chemotherapy

Cisplatin 40mg/m2, qw×5

DRUGImmune induction therapy

Cadonilimab 10mg/kg q3w×2 + albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6

RADIATIONReduced dose radiotherapy

EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4

DRUGDose reduction concurrent chemotherapy

cisplatin 25mg/m2, qw×5

DRUGImmunomaintenance therapy

Cadonilimab 10mg/kg q3w×9 or half a year


Locations(1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07400536


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