Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cadonilimab · 1 trial · 2 indications
multiple endpoint 1: calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
multiple endpoint 2: calculated from randomization to the date of death from any cause.
| Arm | Type | Description |
|---|---|---|
| Cadonilimab arm | EXPERIMENTAL | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Cadonilimab 10mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 14 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively. |
| Chemoradiation arm | ACTIVE_COMPARATOR | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. |
| Name | Type | Description |
|---|---|---|
| Cadonilimab | DRUG | Cadonilimab 10mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 14 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively. |
| Gemcitabine | DRUG | Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. |
| Cisplatin | DRUG | Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation |
| Intensity-modulated radiotherapy | RADIATION | Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions. |
Inclusion Criteria: 1. Patients with histologically confirmed nasopharyngeal carcinoma. 2. Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0). 3. Eastern Cooperative Oncology Group performance status ≤1. 4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet...