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Phase II open label study to evaluate the safety and efficacy of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) in neoadjuvant treatment of cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 | Experimental | Patients will be treated with 1-4 cycles of neoadjuvant AK104. 2-4 weeks after the last cycle of neoadjuvant treatment, patients will undergo radical surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | IV infusion,Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy. | Up to approximately 6 mouths |
| Major pathological response (MPR) rate | MPR rate is defined as the percentage of participants having ≤ 10% viable tumor cells in the pathological examination of resected specimens. | within 14 working days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection rate is defined as the percentage of patients whose post-operative pathology indicate complete tumor resection with all margins being negative. | within 14 working days after operation |
| Pathological Complete Response (pCR) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hanzhong | Zhejiang | 310022 | 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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pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens. |
| within 14 working days after operation |
| Objective response rates (ORR) | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. | 4-6 weeks after the first cycle of neoadjuvant treatment |
| 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 |