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Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.
This prospective single arm study aims to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients. Patients will be given two cycles of TP regimen + Sintilimab, followed by concurrent chemoraiotherapy, and consolidative 6 cycles of Sintilimab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Neoadjuvant chemotherapy (TP regimen) combined with PD-1 inhibitor was given, followed by concurrent chemoradiotherapy (cisplatin and PD-1 inhibitor) , and PD-1 inhibitor maintenance was given sequenced after RT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Chemotherapy (NACT) | Drug | Neoadjuvant chemotherapy: The neoadjuvant regimen prior to radiotherapy consists of paclitaxel 135-175 mg/m², cisplatin 75 mg/m², and Sintilimab 200 mg, administered every 3 weeks for 2 cycles. Concurrent chemoradiotherapy: Radical dose to the pelvic concurrent with cisplatin. Consolidative immunotherapy: Following the completion of chemoradiotherapy, Sintilimab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total of 6 cycles, starting 3-4 weeks after chemoradiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression disease free survival | the time interval from the date of treatment to disease progression, local or distant recurrence | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The number and incidence of adverse events and serious adverse events will be tabulated according to CTCAE 5.0 | one year from the start of immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chen | Contact | 86-21-68383624 | chenhaiyan1220@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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