Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT05813626 | Recruiting Phase 2

• 1 other identifier: NPC-202301
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant chemotherapy plus toripalimab in patients with locoregionally advanced nasopharyngeal carcinoma

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete Response

  CR assessed by investigator, according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI). Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging.

  9 weeks

Secondary Outcomes (5)

• Overall Survival(OS)

  3 years

• Locoregional failure-free survival(LRRFS)

  3 years

• Distant metastasis-free survival(DMFS)

  3 years

• Number of participants with adverse events

  up to 3 years

• Quality of life (QoL): questionnaire

  Week 1,9,16,28

Study Arms (1)

Toripalimab Combined with Induction Chemotherapy

EXPERIMENTAL

Induction chemotherapy (IC; every 3 weeks × 3 cycles; gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1); Toripalimab, 240 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.

Drug: Toripalimab

Interventions

Toripalimab DRUG

Toripalimab (240 mg Q3W for 3 cycles) combine with chemotherapy

Toripalimab Combined with Induction Chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65;
• Pathological type: non-keratinizing carcinoma (World Health Organization criteria);
• Diagnosed with LANPC according to the 8th edition clinical staging system of the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\];
• ECOG performance score: 0 to 1;
• Normal bone marrow function: white blood cell count \> 4×109/L, hemoglobin \> 90g/L, platelet count \> 100×109/L;

You may not qualify if:

• 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;
• 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;
• Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.
• Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA \> 1×10E3 copies/ml; anti-hepatitis C virus positive;
• Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
• 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;
• 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);
• Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
• 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;
• 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;
• Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
• Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
• Allergy to macromolecular protein preparations, or any component of nivolumab;
• Active infection requiring systemic treatment;
• Receiving live vaccine within 30 days of the initial nivolumab;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 14, 2023
• Study Start: April 3, 2023
• Primary Completion: October 30, 2024
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)