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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bispecific Antibody + GP Group | Experimental | Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 yearsï¼› Gemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cyclesï¼› Cisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab | Drug | 10mg/kg administered intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2 years |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;
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).
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kai hu, professor | Contact | +867715356509 | gxhukai@hotmail.com |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | 1 g/m2, administered as an IV infusion within 30 minutes |
|
| Cisplatin | Drug | 80 mg/m2, administered as an IV infusion over 4 hours |
|
Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause. |
| 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. | Up to approximately 2 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |