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This is a single-arm, single-center phase II clinical study to explore the efficacy and safety of sintilimab combined with concurrent chemoradiation therapy as treatment in women with locally advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemoradiotherapy + Sintilimab | Experimental | Participants will be given intravenous administration of sintilimab (200mg, q3w), cisplatin(75 mg/m², q3w) and Radiotherapy. After completing 2 cycles of concurrent chemoradiation, the Participants will continue to use 4 cycles of sintilimab (200mg, q3w) and cisplatin(75 mg/m², q3w) as maintenance therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | IV infusion |
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 2 years | Time from diagnosis of disease to disease progression or death due to any cause |
| Overall survival | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Longzhen Zhang, MD | Contact | 15895236960 | jsxyfyzlz@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Longzhen Zhang, MD | The Affiliated Hospital of Xuzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
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| Drug |
IV infusion |
|
| External Beam Radiotherapy (EBRT) | Radiation | Undergo pelvic EBRT |
|
| brachytherapy | Radiation | brachytherapy |
|
| Time from diagnosis of disease of treatment until death due to any cause |
| Incidence of ADRs and tolerance | 1 years |
| 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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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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