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Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

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

About this trial

This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment;

Not suitable for surgery;

Histologic diagnosis of NPC (WHO II/III);

TNM 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

  • Toripalimab

    Drug

    240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT

  • Chemotherapy

    Drug

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

  • Intensity modulated radiotherapy

    Radiation

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

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: Chemoradiotherapy+anti-PD-1Experimental treatment 3 interventions
Group B: ChemoradiotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Defined as the time from date of recruitment to death from any cause.

Time frame
three years

Secondary outcomes

1

Failure-free survival

Defined as the time from date of recruitment to documented relapse or death from any cause.

Time frame
three years
2

Objective response rate through study completion, an average of nine months

The rate of patients get CR or PR after treatment

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

Disease control rate through study completion, an average of nine months

The rate of patients get CR or PR or SD after treatment

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

Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years

Incidence of nasopharyngeal necrosis and hemorrhage after receiving treatment

Time frame
up to three-year follow-up

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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