Health TrialsbyHealthPanel

Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXinqiao Hospital of Chongqing

About this trial

The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must have signed written informed consent and able to comply with study procedure

18-75 years old

Histologically or cytologically confirmed nasopharyngeal carcinoma

Pathology or imaging confirmed metastatic nasopharyngeal carcinoma.( Clinical stage of IVB according to the 8th edition of AJCC)

Disqualifiers

Allergy to any component of toripalimab

With any active autoimmune disease or a history of autoimmune disease that may relapse

Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally relapsed cancer that has been cured after treatment (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

Received corticosteroid therapy at a dose ≥ 10 mg prednisone per day or any other systemic immunosuppressive therapy within 14 days prior to enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Toripalimab

    Drug

    Toripalimab: 240mg, iv. Q3W for 1 year or until disease progression/intolerable toxicity Radiotherapy: Newly diagnosed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 70 Gy, pGTVnd 99Gy, pCTV1, 60 Gy, pCTV2, 54 Gy, 33 times, completed in 7 weeks. Relapsed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 60Gy, pGTVnd 60Gy, 20-25 times, completed in 4-5 weeks. Newly diagnosed and relapsed patients: SBRT for oligometastatic lesions, pGTV 25-40 Gy, 3-5 times, completed in 1-2 weeks.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Toripalimab +RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year progression-free survival rate according to RECIST v1.1

To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by 1-year progression-free survival rate according to RECIST v1.1

Time frame
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. 1 year

Secondary outcomes

1

PFS according to RECIST v1.1

To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by progression-free survival rate according to RECIST v1.1

Time frame
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
2

OS

To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by overall survival (OS)

Time frame
up to 5 years
3

2-year progression-free survival rate according to RECIST v1.1

To evaluate the PFS rate at 2 years in the treatment arm

Time frame
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
4

2-year overall survival

To evaluate the OS rate at 2 years in the treatment arm

Time frame
From date of randomization until death, loss to follow-up, or study termination by the Sponsor whichever occurs first.Up to 3.5 approximately years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

Southwest Hospital, China

Collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborator

Chongqing University Cancer Hospital

Collaborator

Source ClinicalTrials.gov
Apply now