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SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma

ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed as recurrence/metastatic NPC

Histopathological diagnosis of NPC(WHO II/III)

ECOG 0-1 point

No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;

Disqualifiers

Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;

Unexplained fever > 38.5 #, except for tumor fever;

Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);

Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;

Trial design

Design model

Single group

Treatments tested in this trial

  • SBRT

    Radiation

    SBRT for metastatic lesions

  • Low-dose Radiotherapy (LDRT)

    Radiation

    LDRT for metastatic lesions

  • Toripalimab

    Drug

    6 cycles for combined therapy. Toripalimab maintenance for 1 year.

  • Gemcitabine

    Drug

    6 cycles for combined therapy.

  • Cisplatin

    Drug

    6 cycles for combined therapy.

  • IMRT

    Radiation

    IMRT for primary lesion

Treatment groups

148 Participants
are divided into 1 treatment group
Group A: SBRT+LDRT+PD-1+ChemotherapyExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
up to 12 months

Secondary outcomes

1

Overall Survival

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

Time frame
up to 12 months
2

Objective Response Rate

The percentage of patients with CR and PR assessed according to RECIST v1.1.

Time frame
up to 12 months
3

Disease Control Rate

The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.

Time frame
up to 12 months
4

Adverse Events

All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03

Time frame
up to 12 months

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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