Overview

Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

Status:
Not yet recruiting
Trial end date:
2026-07-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guangxi Medical University
Treatments:
Gemcitabine
Criteria
Inclusion Criteria:

1. The subject must sign the written informed consent form (ICF) voluntarily；

2. Age ≥18 years and ≤65 years；

3. Subjects with histopathological diagnosis of nasopharyngeal carcinoma；

4. 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；

5. Has not received prior systemic treatment;

6. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Status

7. Subject must have a measurable target lesion based on RECIST v1.1;

Exclusion Criteria:

1. Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin,
and other platinum drugs;

2. 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）.

3. 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)；

4. Female patients who are at pregnancy or lactation.