Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

NCT06277050 | Recruiting Phase 3

• 1 other identifier: NPC-ICMB
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 3

Brief Summary

N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure. The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).

Conditions

Nasopharyngeal Carcinoma; High-Risk Cancer; Maintenance Therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Time from date of start of treatment to disease progression or death from any cause.

  3 years

Secondary Outcomes (3)

• Distant Metastasis-Free Survival

  3 years

• Overall Survival

  3 years

• Loco-Regional Recurrence-Free Survival

  3 years

Study Arms (2)

Maintenance Therapy with Toripalimab and Capecitabine

EXPERIMENTAL

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months.

Drug: Maintenance Therapy with Toripalimab and Capecitabine

Maintenance Therapy with Capecitabine alone

ACTIVE COMPARATOR

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months.

Drug: Maintenance Therapy with Capecitabine

Interventions

Maintenance Therapy with Toripalimab and Capecitabine DRUG

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months.

Maintenance Therapy with Toripalimab and Capecitabine

Maintenance Therapy with Capecitabine DRUG

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months.

Maintenance Therapy with Capecitabine alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed nasopharyngeal carcinoma;
• High-risk nasopharyngeal cancer meets one of three points: a. TanyN3M0; b. High-grade rENE, coalescent nodal or invasion of surrounding structures (muscle, skin, nerves, etc.); c. Detectable EBV DNA after 2 cycles of induction chemotherapy.
• years old, both genders; 4. ECOG≤1; 5. Received 2-3 cycles of induction chemotherapy and concurrent chemoradiotherapy (intensity-modulated radiotherapy); 6. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L.
• \. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative; 8. Written informed consent;

You may not qualify if:

• Recurrent or distant metastatic nasopharyngeal carcinoma.
• History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
• Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC
• Has received prior therapy with an anti-PD-1 mab.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• Note: Patients with the following diseases are not excluded and may proceed to further screening:
• Controlled Type I diabetes
• Hypothyroidism (provided it is managed with hormone replacement therapy only)
• Controlled celiac disease
• Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of external triggering factors.
• Any condition that required systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the start of the study。
• Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
• Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
• Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
• Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)。

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (3)

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, 341000, China

NOT YET RECRUITING

First Affiliated hospital of Gannan Medical University

Guangzhou, Jiangxi, 341000, China

RECRUITING

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Nanchang, None Selected, 330029, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Maintenance; toripalimab; Capecitabine

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

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jingao Li

  Jiangxi Provincial Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Jingao Li, MD

CONTACT

86079188300252; lijingao@hotmail.com

Xiaochang Gong, MD

CONTACT

86079188300252; gxcanddw@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): February 20, 2029
• Study Completion (Estimated): February 20, 2030
• Last Updated: April 30, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)