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| Name | Class |
|---|---|
| Hainan People's Hospital | OTHER |
| Wuzhou Red Cross Hospital | OTHER |
| First People's Hospital of Yulin | OTHER |
| Fourth Affiliated Hospital of Guangxi Medical University |
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The purpose of this Phase II, Multicenter, Randomized Controlled Clinical Trial is to evaluate the efficacy and safety of PD-1 inhibitor Plus GP chemotherapy as Neoadjuvant Therapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma.
Induction chemotherapy plus concurrent chemoradiotherapy has the IIA evidence and the gemcitabine plus cisplatin (GP) regimen has the I evidence in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). More and more evidence shows that immunotherapy combined with chemotherapy has a synergistic effect in treating tumors. GP chemotherapy combined with PD-1 inhibitor has achieved the initial effect in NPC. With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. But there are still about 20-30% of NPC patients who experienced recurrence or metastasis after radical chemoradiotherapy, especially locoregionally advanced patients. In order to improve their survival, we conduct this clinical trial to determine whether GP chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy can improve the failure-free survival rate of locoregionally advanced NPC patients and provide new evidence for their neoadjuvant therapy of them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 inhibitor + GP Group | Experimental | PD-1 inhibitor plus GP chemotherapy as Neoadjuvant Therapy followed by IMRT combined with cisplatin concurrent chemotherapy |
|
| GP Group | Active Comparator | GP chemotherapy as Neoadjuvant Therapy chemotherapy followed by IMRT combined with cisplatin concurrent chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor+GP | Drug | PD-1 inhibitor (200-240mg), gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | the time from registration to treatment failure or death from any cause, whichever is first. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) | the complete disappearance of the target and non-target lesion identified at baseline after radiological evaluation by MRI. Disease response was evaluated after the completion of the neoadjuvant therapy, according to RECIST 1.1. | up to 9 weeks |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RENSHENG WANG, MD | First Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
| Guigang People's Hospital | OTHER |
| LiuZhou People's Hospital | OTHER |
| Affiliated Hospital of North Sichuan Medical College | OTHER |
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|
| GP | Drug | Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy. |
|
the time from registration to death due to any cause, or censored at date last known alive. |
| up to 24 months |
| Locoregional failure-free survival(LRRFS) | the time from registration to the first locoregional relapse or death from any cause. | up to 24 months |
| Distant metastasis-free survival(DMFS) | the time from registration to the first distant metastasis or death from any cause. | up to 24 months |
| Adverse events (AEs) | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 | up to 24 months |
| Quality of life(QOL) | Assessed by European Organization for Research and Treatment of Cancer's quality of life questionnaire(QLQ)-C30 | up to 24 months |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |