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PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPC

ConditionsNasopharangeal CancerRecurrent Nasopharynx Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

This phase II randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus selective re-irradiation in locally advanced recurrent nasopharyngeal carcinoma. The study aims to determine whether sequential radiotherapy provides additional survival benefit beyond systemic immunochemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years, any gender.

Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery.

Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).

Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.

Disqualifiers

Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence

Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.

Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.

History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Selective re-irradiation

    Radiation

    PD-1 inhibitor maintenance + Selective re-irradiation PD-1 inhibitor maintenance therapy:Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1; if progression occurs in the nasopharynx or neck, re-irradiation will be administered and PD-1 maintenance will continue until subsequent progression), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

  • Immediate re-irradiation

    Radiation

    Immediate re-irradiation + PD-1 inhibitor Maintenance: Re-irradiation will be administered Immediately. PD-1 inhibitor maintenance therapy: Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Selective re-irradiation groupOther 1 intervention
Group B: Immediate re-irradiation groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

the time from the date of randomization to the date of death due to any cause.

Time frame
3 year

Secondary outcomes

1

Progression free-survival

the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first.

Time frame
3 year
2

Progression free-survival 2

the time from randomization to second/subsequent disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurs first

Time frame
3 year
3

Locoregional progression-free survival

the time from random assignment to the occurrence of a locoregional progression.

Time frame
3 year
4

Distant progression-free survival

Defined as the time from random assignment to the occurrence of a distant progression.

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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