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Recruiting NCT07400536

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

Phase III Interventional Locally Advanced Cervical Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: standard EBRT+Brachytherapy, Concurrent chemotherapy, Immune induction therapy, Reduced dose radiotherapy.
Who it may be relevant to
Registry conditions: Locally Advanced Cervical Carcinoma. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Radiation standard EBRT+Brachytherapy
    EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5
  • Drug Concurrent chemotherapy
    Cisplatin 40mg/m2, qw×5
  • Drug Immune induction therapy
    Cadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6
  • Radiation Reduced dose radiotherapy
    EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4
  • Drug Dose reduction concurrent chemotherapy
    cisplatin 25mg/m2, qw×5
  • Drug Immunomaintenance therapy
    Cadonilimab （Moderate dose）×9 or half a year

Primary outcome measures

  • Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV) [Time frame: Up to approximately 55 months]
Secondary outcome measures (5)
  • Objective Response Rate (ORR) per RECIST 1.1 [Time frame: Up to approximately 55 months]
  • Overall Survival (OS) [Time frame: Up to approximately 55 months]
  • Duration of Response (DOR) per RECIST 1.1 [Time frame: Up to approximately 3 years]
  • Time to Response (TTR) per RECIST 1.1 [Time frame: Up to approximately 3 years]
  • Disease Control Rate (DCR) per RECIST 1.1 [Time frame: Up to approximately 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07400536 · AK104-IIT-CC-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗