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

ConditionLocally Advanced Cervical Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

378 Participants
are divided into 3 treatment groups
Group A: Standard concurrent chemoradiotherapy（CCRT）Active comparator 2 interventions
Group B: Cadonilimab+Induction chemotherapy+reduced-dose CCRT+CadonilimabExperimental treatment 4 interventions
Group C: Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+CadonilimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Up to approximately 55 months

Secondary outcomes

1

Objective Response Rate (ORR) per RECIST 1.1

Assessed by investigators

Time frame
Up to approximately 55 months
2

Overall Survival (OS)

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

Time frame
Up to approximately 55 months
3

Duration of Response (DOR) per RECIST 1.1

Assessed by investigators

Time frame
Up to approximately 3 years
4

Time to Response (TTR) per RECIST 1.1

Assessed by investigators

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Akesobio

Collaborator

Source ClinicalTrials.gov
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