NCT04221516

Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma

Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Phase 2 Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to see how well the experimental drug camrelizumab(SHR-1210) works in people with oligometastatic NPC who have already had locally radiotherapy for their disease. All patients will receive 200 mg of camrelizumab intravenously on Day 1 of each 21-day cycle. Patients will receive the study drug for up to 18 cycles.

Detailed description

Each subject included in this project must sign an informed consent form. Within 4-6 weeks after completing radiotherapy and chemotherapy for oligometastatic lesions, subjects will receive camrelizumab 200 mg fixed-dose treatment every three-week (Q3W). If there is no confirmed disease progression, unacceptable adverse events or concurrent diseases (need further treatment ), the researcher decides to withdraw from the subject, the subject withdraws from treatment, the subject is pregnant, and other reasons that do not meet the requirements of the trial treatment or procedure, The treatment with camrelizumab will last at least 12 months. Patients with no signs of disease progression can be treated with another 6 to 12 months by the decision of researcher. After treatment, each subject will be followed up. Subjects should be monitored for adverse events for at least 30 days, and serious adverse events will be over 90 days. Subjects will be followed up 5 years from the last treatment or until one of the following events: ① disease progression; ② receive other treatments of cancer; ③ withdraw research consent; ④ loss of follow-up; ⑤ death.

Conditions

• Nasopharyngeal Carcinoma
• Oligometastasis
• Radiotherapy

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab 200mg every 21 days (3 weeks) for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2020-01-09
• Last updated: 2023-06-18

Locations

1 site across 1 country: China