Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment(Stage IVb, AJCC/UICC 8th,any T,any N,M1)

Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies

Age ≥18 years and ≤65 years

WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L

Disqualifiers

History of severe anaphylaxis to any component of capecitabine or toripalimab

Active or untreated central nervous system metastases

Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding

Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.

Trial design

Treatments tested in this trial

  • Capecitabine plus toripalimab

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

Hunan Cancer Hospital

Collaborator