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| ID | Type | Description | Link |
|---|---|---|---|
| 2025ZD0544104 | Other Grant/Funding Number | the Noncommunicable Chronic Diseases-National Science and Technology Major Project | |
| 2025YFC3508302 | Other Grant/Funding Number | the National Key Research and Development Program of China, "Modernization of Traditional Chinese Medicine" Major Proje |
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This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings. |
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| Control arm | Active Comparator | Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Therapy Plus Surgery | Procedure | Patients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year progression-free survival (PFS) rate | The proportion of patients who remain alive without radiologically confirmed disease progression at 2 years after randomization. Disease progression will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on imaging evaluations. | 2 years after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wu | Contact | 86 21 33189900 | wuxin_fc@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital of Fudan University | Shanghai | 201101 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D013514 | Surgical Procedures, Operative |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| Concurrent Chemoradiotherapy | Procedure | Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy. |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |