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Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma

ConditionNasopharyngeal Cancinoma (NPC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 Years to 70 Years;

Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III

Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1

T2 and primary gross tumor volume (GTV) greater than 30.0 cm3;

Disqualifiers

Patients have evidence of relapse or distant metastasis

Histologically confirmed keratinizing squamous cell carcinoma (WHO I)

Patients with positive cervical lymph nodes

Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.).

Trial design

Design model

Single group

Treatments tested in this trial

  • Without prophylactic neck irradiation

    Radiation

    Intensity-modulated radiotherapy restricted to the primary tumor, omitting prophylactic neck irradiation.

  • PD-1 antibody (Toripalimab)

    Drug

    Toripalimab 240mg every 2 weeks with a total of 2 cycles as neoadjuvant anti-PD-1 immunotherapy; Toripalimab 240mg every 3 weeks with a total of 8 cycles as adjuvant anti-PD-1 immunotherapy after CCRT

  • Cisplatin

    Drug

    Cisplatin 100mg/m2(every three weeks), Day 1, Day 22, Day 43 of intensity modulated radiotherapy

Treatment groups

59 Participants
are divided into 1 treatment group
Group A: Toripalimab groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Regional relapse-free survival (RRFS)

Defined as the time from registration to documented nodal relapse or non-cancer-specific death.

Time frame
2 years

Secondary outcomes

1

Progress-free survival (PFS)

Defined as the time from registration to documented disease progression or non-cancer-specific death.

Time frame
2 years
2

Overall Survival (OS)

Defined as the time from registration to death from any cause.

Time frame
2 years
3

Locoregional Relapse-Free Survival (LRRFS)

Defined as the time from registration to documented locoregional recurrence or non-cancer-specific death.

Time frame
2 years
4

Distant Metastasis-Free Survival (DMFS)

Defined from registration to documented distant metastasis or noncancer-specific death.

Time frame
2 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

This trial is not recruiting at the moment. You can still explore other options: