Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab, salvage surgery.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma, PD-1, Surgery. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial
Overview
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.
Detailed description
Through multicenter, open-label, randomised clinical trials, patients with resectable locally recurrent nasopharyngeal carcinoma are randomized into salvage surgery plus PD-1 treatment group and salvage surgery alone group. The efficacy and safety of patients between these two groups are compared.
Interventions
- Drug Toripalimab
Toripalimab: 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. - Procedure salvage surgery
Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.
Primary outcome measures
- Disease-free survival [Time frame: 2 years]
Secondary outcome measures (7)
- Objective Response Rate [Time frame: 3-5 weeks]
- Major Pathological Response Rate [Time frame: 4-6 weeks]
- Overall Survival [Time frame: 2 years]
- Distant Metastasis-Free Survival [Time frame: 2 years]
- Locoregional Relapse-Free Survival [Time frame: 2 years]
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) [Time frame: up to 2 years]
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) [Time frame: up to 2 years]
Eligibility criteria
Inclusion criteria
- 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)
- Given written informed consent.
Exclusion criteria
- 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.
- Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
- Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
- Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
- Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
- Has received a live vaccine within 4 weeks of planned start of study treatment.
- Pregnancy or breast feeding.
- Cannot complete regular follow-up.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 7 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou
- Nanfang Hospital of Southern Medical University — Guangzhou
- The Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou
- The First People's Hospital of Foshan — Guangzhou
- Zhongshan People's Hospital — Zhongshan
- The Tenth Affiliated Hospital, Sun Yat-Sen University — Nanchang
Identifiers
NCT: NCT04778956 · SYSUCC-CMY-2020-2302