Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangxi Medical University
About this trial
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.
Eligibility criteria
Qualifiers
The subject must sign the written informed consent form (ICF) voluntarily；
Age ≥18 years and ≤65 years；
Subjects with histopathological diagnosis of nasopharyngeal carcinoma；
Primarily metastatic (stage IVB as defined by AJCC staging system for NPC, eighth edition) or recurrent/metastatic NPC that is not amenable to local regional treatment or curative treatment and at least 6 months after radical treatment；
Disqualifiers
Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;
Any active malignancy ≤ 2 years before randomization except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)；
Female patients who are at pregnancy or lactation.
Trial design
Treatments tested in this trial
- Cadonilimab
- Gemcitabine
- Cisplatin
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
This trial has no locations
Sponsors and collaborators
Guangxi Medical University
Lead sponsor
Source ClinicalTrials.gov