Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT03130270|
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: Apatinib mesylate tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Maintenance Apatinib After Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||April 8, 2019|
|Estimated Study Completion Date :||December 8, 2019|
Experimental: Apatinib group
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).
Drug: Apatinib mesylate tablet
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.
Other Name: No.
- Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma [ Time Frame: up to 24 months ]To evaluate ORR every 6-8 weeks after initiation of apatinib.
- Disease-free survival (DFS) [ Time Frame: up to 24 months ]The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death.
- Overall survival (OS) [ Time Frame: up to 24 months ]The time from the first day of therapy to death or last follow-up.
- Toxicity evaluation [ Time Frame: up to 24 months ]Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130270
|Guilin Medical University|
|Guilin, Guangxi, China, 541001|
|Guilin, Guangxi, China|
|National Hospital of Guangxi Zhuang Autonomous Region|
|Nanning, Guangxi, China|
|Wuzhou Red Cross Hospital|
|Wuzhou, Guangxi, China|
|Principal Investigator:||Wei Jiang||Guilin Medical University|