Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The recurrence time is more than 6 months from the end of radiotherapy.
Histologically confirmed recurrent nasopharyngeal carcinoma.
Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
Disqualifiers
Karnofsky Performance Status (KPS) ≤70.
Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
Has known subjects with other malignant tumors.
Has participated in other drug trials within 3 months of planned start of study treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Toripalimab
DrugToripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
salvage surgery
Procedure/SurgeryEndoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.
Treatment groups
218 Participants
are divided into 2 treatment groupsGroup A: Toripalimab plus salvage surgeryExperimental treatment 2 interventions
Group B: Salvage surgery aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disease-free survival
Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.
Time frame
2 yearsSecondary outcomes
1
Objective Response Rate
Defined as the proportion of patients with radiologically confirmed complete or partial response according to RECIST 1.1.
Time frame
3-5 weeks2
Major Pathological Response Rate
Defined as the proportion of patients with no more than 10% viable tumor cells which is identified on routine hematoxylin and eosin staining within the recurrent nasopharyngeal tumor and/or regional lymph node after neoadjuvant PD-1 treatment.
Time frame
4-6 weeks3
Overall Survival
Defined as the time interval from randomization to death due to any cause.
Time frame
2 years4
Distant Metastasis-Free Survival
Defined as the time interval from randomisation to the date of first distant metastases.
Time frame
2 yearsSponsors and contacts
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Sun Yat-sen University
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First People's Hospital of Foshan
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Tenth Affiliated Hospital, Sun Yat-sen University
Collaborator
Source ClinicalTrials.gov