A Phase 3 interventional study of PD-1 blocking antibody and Gemcitabine in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Recruiting at 26 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.
The goals of this clinical trial includes: ① To confirm whether LRRFS after reduced-dose radiotherapy in combination with chemotherapy and immunotherapy is non-inferior to LRRFS after conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response; ② To explore the impact of reduced-dose radiotherapy on 3-year OS, 3-year PFS, 3-year DMFS, 3-year LRFS and 3-year RRFS for treatment-sensitive stage III NPC patients screened out according to the treatment response; ③ To explore the impact of reduced-dose radiotherapy on radiotherapy complications and quality of life; ④ To explore the interaction between different clinical factors and the impact of reduced-dose radiotherapy on the prognosis of patients; ⑤ To explore the biomarkers of sensitivity to chemotherapy and radiotherapy for patients with nasopharyngeal carcinoma and the underlying mechanism.
For these purposes, we plan to prospectively enroll stage III NPC patients from hospitals in China. The participants will receive 3 cycles of induction chemotherapy (GP regimen + Camrelizumab) followed by intensity-modulated radiation therapy. 2 cycles of concurrent chemotherapy will be administered during the radiotherapy. Patients' treatment response will be evaluated with MRI examination after 27 fractions of radiotherapy. If the treatment response after 27 fractions of radiotherapy is complete remission, the participants will be randomized into reduced-dose radiotherapy group and conventional-dose radiotherapy group. If the treatment response after 27 fractions of radiotherapy is not complete remission, the participants will be assigned to the unenrolled group. All the participants in the unenrolled group will receive conventional-dose radiotherapy. After the radiotherapy, all the participants will receive 9 cycles of Camrelizumab immunotherapy. Besides, all the participants in the unenrolled group will also receive metronomic adjuvant capecitabine chemotherapy for 1 year. The prognosis, complication, and quality of life will be compared between the reduced-dose radiotherapy group and the conventional-dose radiotherapy group.
816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.
This study's planned enrollment of 593 is above the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.
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Exclusion Criteria:
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.
Drug: PD-1 blocking antibody · Drug: Gemcitabine · Drug: Cisplatin (80 mg/m2) · Radiation: Reduced-dose Intensity-modulated radiotherapy · Drug: Cisplatin (100 mg/m2)
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.
Drug: PD-1 blocking antibody · Drug: Gemcitabine · Drug: Cisplatin (80 mg/m2) · Radiation: Conventional-dose Intensity-modulated radiotherapy · Drug: Cisplatin (100 mg/m2)
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.
Drug: PD-1 blocking antibody · Drug: Gemcitabine · Drug: Cisplatin (80 mg/m2) · Radiation: Conventional-dose Intensity-modulated radiotherapy · Drug: Cisplatin (100 mg/m2) · Drug: Capecitabine
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.
Also known as: Camrelizumab
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.
Also known as: GEM
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Also known as: DDP
1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.
Also known as: Reduced-dose IMRT
1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.
Also known as: Conventional-dose IMRT
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles
Also known as: DDP
Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.
Locoregional failure-free survival (LRFFS)
Locoregional failure-free survival is measured from day of diagnosis until local or regional recurrence.
Time frame: 3-year
Overall survival (OS)
Overall survival is measured from day of diagnosis until death from any cause.
Time frame: 3 year
Failure-free survival (FFS)
Failure-free survival is measured from day of diagnosis until local recurrence, regional recurrence, distant failure, or death from any cause, whichever occurred first.
Time frame: 3 year
Distant failure-free survival (DFFS)
Distant failure-free survival is measured from day of diagnosis until distant failure.
Time frame: 3 year
Local failure-free survival (LFFS)
Local failure-free survival is measured from day of diagnosis until local recurrence.
Time frame: 3 year
Regional failure-free survival (RFFS)
Regional failure-free survival is measured from day of diagnosis until regional recurrence.
Time frame: 3 year
Incidence rate of investigator-reported radiotherapy-related complications
Time frame: Within (acute complication) / since (late complication) 90 days after the radiotherapy onset.
Incidence rate of patient-reported adverse events
Time frame: 3 year
Quality of life (QoL): questionnaire
Time frame: Regular evaluation after 30 fractions of radiotherapy.
Plan to share: No — Complete de-identified patient data set will be submitted onto the Research Data Deposit (RDD) public platform (http://www.researchdata.org.cn) and available from the principal investigators upon reasonable request.
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