Overview

PD-1 Blockade Combined With De-intensification Radical Chemoradiotherapy in Nasopharyngeal Carcinoma

Status:
Not yet recruiting
Trial end date:
2027-10-01
Target enrollment:
0
Participant gender:
All
Summary
This is a phase 3, multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 blockade (toripalimab) combined with the de-intensification radical chemoradiotherapy sparing concurrent cisplatin (i.e., toripalimab plus induction chemotherapy followed by radiotherapy alone) in high-risk locoregionally advanced nasopharyngeal carcinoma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborator:
Shanghai Junshi Bioscience Co., Ltd.
Treatments:
Antibodies
Antibodies, Blocking
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:

1. Age: 18 to 65;

2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria);

3. Diagnosed with LANPC (T4N1, T1-4N2-3) according to the 8th edition clinical staging
system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer
Control [UICC];

4. ECOG performance score: 0 to 1;

5. Normal bone marrow function: white blood cell count > 4×109/L, hemoglobin > 90g/L,
platelet count > 100×109/L;

6. Normal values of thyroid function, amylase and lipase examination, pituitary function,
inflammation and infection indicators, myocardial enzymes, and ECG results. For
patients older than 50 years with a smoking history, normal lung function are
required. Patients with abnormal ECG and/or a history of vascular disease (but not
meeting the exclusion criteria listed in the exclusion criteria 7) need further
testing and require normal results of myocardial function and color Doppler
ultrasound.

7. Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN);
alanine transaminase and aspartate transaminase ≤ 2.5 × ULN; alkaline phosphatase ≤
2.5 × ULN; creatinine clearance rate ≥ 60 ml/min;

8. Patients must sign informed consent and be willing and able to comply with the
requirements of visits, treatment, laboratory tests and other research requirements
stipulated in the research schedule;

9. Subjects with pregnancy ability must agree to use reliable contraceptive measures from
screening to 1 year after treatment.

Exclusion Criteria:

1. Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA > 1×10E3 copies/ml;
anti-hepatitis C virus positive;

2. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune
deficiency syndrome (AIDS);

3. Active tuberculosis: active tuberculosis in the past 1 year should be excluded
regardless with treatment; history of active tuberculosis over 1 year should be
excluded except that previous regulatory anti-tuberculosis treatment is proved;

4. Active, known or suspected autoimmune disease (including but not limited to uveitis,
enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism,
hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes
mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders
requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);

5. Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid
therapy;

6. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg
prednisone per day) or any other form of immunosuppressive therapy. Subjects who used
inhaled or topical corticosteroids were eligible;

7. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2); 2)
unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or
ventricular arrhythmia requiring treatment or intervention;

8. Pregnant or lactating women (pregnancy test should be considered for women with sexual
life and fertility);

9. Previous or concurrent with other malignant tumors, except for adequately treated
non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;

10. Allergy to macromolecular protein preparations, or any component of nivolumab;

11. Active infection requiring systemic treatment;

12. Receiving live vaccine within 30 days of the initial nivolumab;

13. History of organ transplantation;

14. History of psychotropic disease, alcoholism or drug abuse; other situation assessed by
the investigators that may compromise the safety or compliance of patients, such as
serious disease requiring timely treatment (including mental illness), severe
laboratory abnormalities, or family-social risk factors.