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Clinical Trial Summary

to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.


Clinical Trial Description

This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05484375
Study type Interventional
Source Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Contact Yin Wen-Jing
Phone 0086-13929503157
Email wenjing1342@163.com
Status Not yet recruiting
Phase Phase 2
Start date September 2022
Completion date September 2029

See also
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Active, not recruiting NCT04586088 - Apatinib and Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma With First-line Treatment Failure Phase 2
Active, not recruiting NCT04405622 - Toripalimab and Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma. Phase 2
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Active, not recruiting NCT04872582 - Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study Phase 2
Completed NCT01392235 - Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC) Phase 2
Terminated NCT04458909 - Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer Phase 3
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Recruiting NCT04627961 - A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2