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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06239727 | Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response | PHASE3 | RECRUITING | 593 | — | — | Mar 1, 2024 | Feb 20, 2030 | Mar 6, 2026 | 26 | China |
| NCT04907370 | PD-1 Blockade Combined With De-intensified Chemoradiotherapy Sparing Concurrent Cisplatin in Nasopharyngeal Carcinoma | PHASE3 | ACTIVE NOT_RECRUITING | 532 | — | — | Aug 1, 2021 | Mar 1, 2027 | Jul 16, 2025 | 12 | China |
Locoregional failure-free survival is measured from day of diagnosis until local or regional recurrence.
Failure-free survival is measured from day of diagnosis until treatment failure, death from any cause, or last follow-up visit, whichever occurred first
Incidence rate of all-grade vomiting during treatment assessed by clinicians according to the Common Terminology Criteria for Adverse Events 5.0.
| Arm | Type | Description |
|---|---|---|
| Reduced-dose radiotherapy group | EXPERIMENTAL | All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by reduced-dose intensity-modulated radiation therapy (IMRT; 6360cGy, 30 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles. |
| Conventional-dose radiotherapy group | ACTIVE_COMPARATOR | All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles. |
| Not-Randomized population | OTHER | All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles. Besides, all the participants should also receive metronomic adjuvant capecitabine chemotherapy (capecitabine 650 mg/m2 p.o. BID 1 year) immediately after the completion of concurrent chemoradiotherapy. |
| Toripalimab Combined with Induction Chemotherapy Followed by Radiotherapy Alone | EXPERIMENTAL | All participants will receive induction chemotherapy (IC; every 3 weeks × 3 cycles; gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1) followed by intensity-modulated radiotherapy (IMRT; 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day) alone. PD-1 blockade toripalimab (240 mg per cycle) will start on day 1 of the first cycle IC and continue every 3 weeks for 6 cycles till the end of IMRT, involving the whole-course of IC + IMRT alone. The first and last 3 cycles of toripalimab are administrated concurrently with IC and IMRT, respectively. After 3 weeks of the completion of IMRT, adjuvant toripalimab (240 mg per cycle) will begin every 3 weeks for 11 cycles. |
| Toripalimab Combined with Induction Chemotherapy Followed by Concurrent Chemoradiotherapy | ACTIVE_COMPARATOR | All participants will receive induction chemotherapy (IC; every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1) followed by concurrent chemoradiotherapy (CCRT; every 3 weeks × 2 cycles of cisplatin + IMRT 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day). PD-1 blockade toripalimab (240 mg per cycle) will start on day 1 of the first cycle IC and continue every 3 weeks for 6 cycles till the end of CCRT, involving the whole-course of IC + CCRT. The first and last 3 cycles of toripalimab are administrated concurrently with IC and CCRT, respectively. After 3 weeks of the completion of CCRT, adjuvant toripalimab (240 mg per cycle) will begin every 3 weeks for 11 cycles. |
| Name | Type | Description |
|---|---|---|
| PD-1 blocking antibody | DRUG | 1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC. 2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1. |
| Gemcitabine | DRUG | Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles. |
| Cisplatin (80 mg/m2) | DRUG | Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles. |
| Reduced-dose Intensity-modulated radiotherapy | RADIATION | 1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F. |
| Conventional-dose Intensity-modulated radiotherapy | RADIATION | 1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F. |
| Cisplatin (100 mg/m2) | DRUG | Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles |
| Capecitabine | DRUG | Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy. |
| Cisplatin (80mg/m2) | DRUG | Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles |
| Cisplatin (100mg/m2) | DRUG | Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles |
| Intensity-modulated radiotherapy | RADIATION | Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day |
Inclusion Criteria: 1. Age: 18 Years to 65 Years; 2. Eastern Cooperative Oncology Group performance status ≤1; 3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma; 4. Tumor staged as Stage III (T3N0 Excepted; AJCC ...