Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial

Cancer Hospital of Guangxi Medical University

Status and phase: Unknown; Phase 2

Conditions: Recurrent Nasopharyngeal Squamous Cell Carcinoma; Nasopharyngeal Carcinoma; Toripalimab

Treatments: Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04992988

KY2020163

Details and patient eligibility

About

This is a prospective, single-arm, phase II trial to study the efficacy of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy in treating patients with locoregionally recurrent nasopharyngeal carcinoma.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrence tumor
2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
6. With normal renal function test ( creatinine clearance ≥60 ml/min)
7. sign an "informed consent form
8. Male and no pregnant female

Exclusion criteria

1. Age> 70, or < 18 years old
2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
3. Patients with positive HCV antibody.
4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
5. History of interstitial lung disease
6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.
8. Women of child-bearing potential who are pregnant or breastfeeding.
9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.
11. HIV positive.
12. Severe, uncontrolled medical conditions and infections.
13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Toripalimab+CCRT

Experimental group

Description:

Cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy. Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 3 weeks after CCRT

Treatment:

Drug: Toripalimab