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PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

ConditionRecurrent Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;

Not suitable for surgery;

Newly histologic diagnosis of NPC (WHO II/III);

Clinical stage rII-IVa (AJCC/UICC 8th);

Disqualifiers

Treated with anti-tumor Chinese medicine treatment;

Have recurrence with local necrosis;

Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;

Unexplained fever > 38.5 ℃, except for tumor fever;

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 blocking antibody

    Drug

    Toripalimab 240mg, D1, every 3 weeks per cycle

  • GP

    Drug

    Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles

  • IMRT

    Radiation

    IMRT 60-66Gy, 1.8-2.0Gy/f/day

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: PD-1 antibody plus chemoradiotherapyExperimental treatment 3 interventions
Group B: ChemoradiotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival

From date of randomisation to death

Time frame
3 years

Secondary outcomes

1

Progression free survival

From date of randomisation to disease progression

Time frame
3 years
2

Short-term effects

Patient's objective response rate

Time frame
through study completion, an average of 2 months
3

Rate of patients with acute toxicities

Evaluating with CTCAE v5.0

Time frame
through study completion, an average of 2 months
4

Quality of life: EuroQoL 5 dimension

Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)

Time frame
through whole study, an average of 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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