Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07459296 | Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC | PHASE3 | RECRUITING | 266 | — | — | Mar 5, 2026 | Apr 1, 2032 | Mar 16, 2026 | 1 | China |
The time interval from randomization to the first treatment failure or the last follow-up if there is no treatment failure. Treatment failure is defined as local/cervical residual disease 16 weeks after radiotherapy, local/cervical recurrence, distant metastasis, or death due to any cause,whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Becotatug Vedotin followed by CCRT plus Sintilimab | EXPERIMENTAL | Patients will receive Becotatug Vedotin induction therapy followed by CCRT combined with neoadjuvant and adjuvant sintilimab |
| Induction Chemotherapy followed by CCRT | ACTIVE_COMPARATOR | Patients will receive gemcitabine plus cisplatin induction chemotherapy followed by CCRT |
| Name | Type | Description |
|---|---|---|
| Becotatug Vedotin | DRUG | Becotatug vedotin 2.3 mg/kg will be given on Day 1 of induction therapy, once every 3 weeks for a total of 3 cycles. |
| Sintilimab | DRUG | In the induction treatment phase, sintilimab 200 mg will be administered on Day 1 of each induction cycle, once every 3 weeks, for a total of 3 cycles. In the adjuvant treatment phase, sintilimab 200 mg will be given on Day 1, initiated 3 weeks after the completion of radiotherapy, once every 3 weeks, for a total of 9 cycles. |
| Cisplatin | DRUG | 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 |
| Gemcitabine (GEM) | DRUG | Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. |
Inclusion Criteria: 1. Voluntarily participate in the study and sign the informed consent form in writing. 2. Aged 18-70 years, male or non-pregnant female. 3. Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III). ...