A Phase 1/2 interventional study of Cadonilimab and Gemcitabine in Nasopharyngeal Carcinoma and Immune Checkpoint Inhibitors, sponsored by Guangxi Medical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Guangxi Medical University · Phase 1/2, Interventional, and Treatment
This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Cadonilimab in combination with gemcitabine/cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Guangxi Medical University is the lead sponsor of 68 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prior therapy as follow:
Anti-PD-1, anti-PD-L1 or anti-CTLA-4; Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment（Except：inhalation or topical corticosteroids）.
Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 years； Gemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cycles； Cisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles.
Drug: Cadonilimab · Drug: Gemcitabine · Drug: Cisplatin
10mg/kg administered intravenously (IV)
Also known as: AK104
1 g/m2, administered as an IV infusion within 30 minutes
80 mg/m2, administered as an IV infusion over 4 hours
Objective response rate(ORR)
ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
Time frame: Up to approximately 2 years
Incidence and severity of adverse events(AEs)
Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with chemotherapy.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.
Time frame: Up to approximately 2 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Guangxi Medical University