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NCT Number: NCT07400536

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Wuhan, Hubei, China

Location status: Recruiting

Location contact

Yuling Zhang

CONTACT

[email protected]

(+86)027-85726685

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

standard EBRT+Brachytherapy

Radiation

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

×5

Concurrent chemotherapy

Drug

Cisplatin 40mg/m2, qw×5

Immune induction therapy

Drug

Cadonilimab (Moderate dose)+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6

Reduced dose radiotherapy

Radiation

EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4

Dose reduction concurrent chemotherapy

Drug

cisplatin 25mg/m2, qw×5

Immunomaintenance therapy

Drug

Cadonilimab (Moderate dose)×9 or half a year

Primary outcomes

  1. Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV)

    Time frame: Up to approximately 55 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Objective Response Rate (ORR) per RECIST 1.1

    Time frame: Up to approximately 55 months

    Assessed by investigators

  2. Overall Survival (OS)

    Time frame: Up to approximately 55 months

    OS is defined as the time from randomization to death due to any cause.

  3. Duration of Response (DOR) per RECIST 1.1

    Time frame: Up to approximately 3 years

    Assessed by investigators

  4. Time to Response (TTR) per RECIST 1.1

    Time frame: Up to approximately 3 years

    Assessed by investigators

  5. Disease Control Rate (DCR) per RECIST 1.1

    Time frame: Up to approximately 3 years

    Assessed by investigators

Study contacts

Contact information is provided by the study sponsor or research team.

Guiling Li, PHD

CONTACT

(+86)027-85726685

Ting Liu, MD

CONTACT

[email protected]

+86 (0760) 8987 3999

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Akesobio

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Feb 10, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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