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This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol. Subjects who finished treatment entered the safety follow-up or survival follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with primary IB2-IIIB cervical cancer | Experimental | Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab plus Concurrent chemoradiotherapy | Combination Product | Participants will be given intravenous administration of Camrelizumab (200mg,every 2 weeks),Cisplatin(40mg/m²,everyweek) and Radiotherapy. After completing 6~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year OS rate | Patient proportion to survival in the third year | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | The period of time between when a patient with neoplastic disease receives treatment and when the disease progresses or death from any cause occurs. | 24 months |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | 86-139-1198-8831 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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|
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission(CR) and partial remission(PR).
| 12 months |
| Acute Adverse Events (AEs) | The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 5.0 | 36 months |
| 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 |
|---|---|
| C000631724 | camrelizumab |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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