Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Surgery; Nasopharyngeal Carcinoma; PD-1

Treatments: Drug: Toripalimab; Procedure: salvage surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04778956

SYSUCC-CMY-2020-2302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The recurrence time is more than 6 months from the end of radiotherapy.
2. Histologically confirmed recurrent nasopharyngeal carcinoma.
3. 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)
4. 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)
5. Given written informed consent.

Exclusion criteria

1. Karnofsky Performance Status (KPS) ≤70.
2. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
3. Has known subjects with other malignant tumors.
4. Has participated in other drug trials within 3 months of planned start of study treatment.
5. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
6. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
7. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
8. 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.
9. 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.
10. Has received a live vaccine within 4 weeks of planned start of study treatment.
11. Pregnancy or breast feeding.
12. Cannot complete regular follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Toripalimab plus salvage surgery

Experimental group

Description:

1. Toripalimab: Toripalimab treatment before and after salvage surgery. 2. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.

Treatment:

Drug: Toripalimab

Procedure: salvage surgery

Salvage surgery alone

Active Comparator group

Description:

1. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.

Treatment:

Procedure: salvage surgery