NCT07400536 A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT
| NCT ID | NCT07400536 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Locally Advanced Cervical Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2028-07-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 378 participants in total. It began in 2026-04-24 with a primary completion date of 2028-07-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Guiling Li, PHD
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT07400536 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Locally Advanced Cervical Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07400536 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 378 participants.
Is NCT07400536 currently recruiting?
Yes, NCT07400536 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT07400536 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07400536 clinical trial?
NCT07400536 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Guiling Li, PHD at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 378 participants.