Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Sanbo Brain Hospital
About this trial
This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
Measurable focus in MRI (>10x10mm);
Aged > 18 years;
Disqualifiers
Concurrent administration of any other antitumor therapy；
Allergic to the ingredients of research drugs；
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；
Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function；
Trial design
Design model
Single group
Treatments tested in this trial
Camrelizumab
DrugCamrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: CamrelizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR(objective response rate)
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Time frame
Up to three yearsSecondary outcomes
1
The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease)
Describe the best therapeutic response of patients treated with Camrelizumab
Time frame
Up to three years2
PFS(progression free survival)
the time from randomization until objective tumor progression or death
Time frame
Up to three years3
OS(overall survival)
the time from randomization until death from any cause and is measured in the intent-to-treat population
Time frame
Up to three years4
ADEs( adverse events)
Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.
Time frame
Up to three yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov