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To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer
A total of 47 patients will be enrolled in this study. After screening, patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles. CT/MR of chest, upper and lower abdomen and pelvic MR will be performed before treatment and 2 weeks after the 3rd cycle chemotherapy. The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1. Radical surgery will be performed after NACT. According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated. The adverse events will be continuously monitored during treatment until 30 days after chemotherapy. Toxic adverse events is evaluated according to NCI-CTCAEv5.0 criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel + cisplantin + Sindilimab | Experimental | standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles paclitaxel 150mg/m2,ivdrip,>3 hours cisplantin 70mg/m2,ivdrip,>1 hours Sindilimab 200mg,ivdrip, >0.5 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sindilimab +paclitaxel+ cisplantin | Drug | standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete remission rate (pCR) rate | According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) (CR + PR) | The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihong Liu, Ph.D. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University cancer center | Guangzhou | Guangdong | 510000 | China |
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patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles
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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 |
| 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 |
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