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Adaptive Immunotherapy for Nasopharyngeal Carcinoma

ConditionNasopharyngeal Cancinoma (NPC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy. 2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-65 years;

Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);

Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;

ECOG performance status: 0-1;

Disqualifiers

T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;

Disease progression after induction therapy;

Hepatitis B surface antigen (HBsAg) positive with HBV DNA >1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;

Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radical radiotherapy of nasopharynx and neck

    Radiation

    Radical radiotherapy of nasopharynx and neck

  • Capecitabine

    Drug

    Adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year

  • Concurrent chemoradiotherapy (cCRT)

    Drug

    Concurrent chemoradiotherapy

  • Toripalimab

    Drug

    Adjuvant Toripalimab (240mg day1, Q3W )

Treatment groups

802 Participants
are divided into 4 treatment groups
Group A: Low risk arm 1Experimental treatment 2 interventions
Group B: Low risk arm 2Active comparator 3 interventions
Group C: High risk arm 1Experimental treatment 4 interventions
Group D: High risk arm 2Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Event-free survival

The primary endpoint was event-free survival from randomisation to disease recurrence (locoregional or distant) or death from any cause in the intention-to-treat population.

Time frame
3 year
2

Incidence rates of vomiting as assessed by CTCAE v5.0

In the low-risk arm, the primary outcome included the incidence rates of vomiting (evaluated according to the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).

Time frame
3 year

Secondary outcomes

1

Overall survival

The secondary endpoint include overall survivall from randomisation to death from any cause in the intention-to-treat population.

Time frame
3 year
2

Locoregional relapse-free survival

The secondary endpoint include locoregional relapse-free survival from randomisation to local and/or regional relapse or death from any cause in the intention-to-treat population.

Time frame
3 year
3

Distant metastasis-free survival

The secondary endpoint include distant metastasis-free survival from randomisation to distant metastasis or death from any cause in the intention-to-treat population.

Time frame
3 year
4

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Acute and late treatment-related adverse events will be assessed by the CTCAE v 5.0(Common Terminology Criteria for Adverse Events, version 5.0).

Time frame
3 year

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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