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Clinical Trials in China / NCT07400536
Recruiting Phase 3

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

NCT07400536 · tracked via the Priya Life Science China tracker
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Phase 3
Started
2026-04-24
Last updated
2026-05-13

Condition(s) studied

Locally Advanced Cervical Carcinoma

Investigational drug(s) / intervention(s)

standard EBRT+BrachytherapyConcurrent chemotherapyImmune induction therapyReduced dose radiotherapyDose reduction concurrent chemotherapyImmunomaintenance therapy

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

Concurrent chemotherapy: Cisplatin 40mg/m2, qw×5

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

Reduced dose radiotherapy: EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4

Dose reduction concurrent chemotherapy: cisplatin 25mg/m2, qw×5

Immunomaintenance therapy: Cadonilimab (Moderate dose)×9 or half a year

Study 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
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: To be enrolled, subjects had to meet all of the following criteria: 1. Female, aged 18-70 years (inclusive of cutoff values); 2. Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; 3. Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy; 4. At least one measurable lesion according to RECIST v1.1; 5. Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1; 6. Have adequate organ function. Exclusion Criteria: Subjects were excluded from the study if they met any of the following criteria: 1. 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); 2. He had undergone total hysterectomy (removal of the corpus uteri and cervix); 3. Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities; 4. Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy); 5. Had any condition that was deemed by other investigators to be ineligible for participation in the trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07400536 on ClinicalTrials.gov ↗ ← All trials in China