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| Name | Class |
|---|---|
| Wuzhou Red Cross Hospital | OTHER |
| Guangxi Naxishan Hospital | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
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The study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of drug safety.
In locally advanced nasopharyngeal carcinoma(NPC), although fist-line therapy with radiotherapy and chemotherapy (Cisplatin/Docetaxel/5-Fu) and second-line therapy with chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for locally recurrent or metastatic NPC who failed to second-line therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib in locally recurrent or metastatic NPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib group | Experimental | Apatinib mesylate tablet:the starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib mesylate tablet | Drug | Patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) after second-line treatment are assigned to receive apatinib mesylate tablet. A treatment cycle was defined as 28 days (4 weeks). The starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). All patients continuous treatment until progression disease or non-tolerated toxicity. Note: good tolerance was defined that no grade 3/4 hematology or/and non hematologic side effects occurred within 4 weeks after initiation treatment; poor tolerance was defined that grade 3/4 hematology or/and non hematologic side effects appeared within 4 weeks after initiation treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma | To evaluate ORR every 6-8 weeks after initiation of apatinib. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death. | up to 24 months |
| Overall survival (OS) | The time from the first day of therapy to death or last follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Jiang | Guilin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guilin Medical University | Guilin | Guangxi | 541001 | China | ||
| Nanxishan hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34043812 | Derived | Ruan X, Liang JH, Pan Y, Cai R, Zhang RJ, He Z, Yang X, Niu Z, Jiang W. Apatinib for the treatment of metastatic or locoregionally recurrent nasopharyngeal carcinoma after failure of chemotherapy: A multicenter, single-arm, prospective phase 2 study. Cancer. 2021 Sep 1;127(17):3163-3171. doi: 10.1002/cncr.33626. Epub 2021 May 27. |
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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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| ID | Term |
|---|---|
| C553458 | apatinib |
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|
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| up to 24 months |
| Toxicity evaluation | Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | up to 24 months |
| Guilin |
| Guangxi |
| China |
| National Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China |
| Wuzhou Red Cross Hospital | Wuzhou | Guangxi | China |
| 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 |