RecruitingPhase 3NCT06277050
Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)
Sponsor
Jiangxi Provincial Cancer Hospital
Enrollment
264 participants
Start Date
Mar 7, 2024
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria4
- 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;
Exclusion Criteria38
- 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)。
- With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
- Severe infections within 4 weeks before the start of the study, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Received therapeutic oral or intravenous antibiotics within 2 weeks before start of the study.
- A known history of HIV infection
- Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is \>1000 IU/mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \<1000 IU/mL), and cured hepatitis C patients can be enrolled.
- Any major surgical procedure requiring general anaesthesia ≤28 days before start of study。
- Prior allogeneic stem cell transplantation or organ transplantation.
- Any of the following cardiovascular risk factors:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤28 days before start of study
- Pulmonary embolism ≤28 days before start of study
- Any history of acute myocardial infarction ≤6 months before start of study
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤6 months before start of study
- Any event of ventricular arrhythmia ≥Grade 2 in severity ≤6 months before start of study
- Any history of cerebrovascular accident ≤6 months before start of study
- Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite anti-hypertension medications ≤28 days before start of study
- Any episode of syncope or seizure ≤28 days before start of study.
- A history of severe hypersensitivity reactions to toripalimab, capecitabine and/or any of its excipients.
- Has received any herbal medicine used to control cancer within 14 days of the start of study
- Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)
- Concurrent participation in another therapeutic clinical study
- Emotional disturbance or mental illness
- Refusal or inability to sign informed consent
Interventions
DRUGMaintenance Therapy with Capecitabine
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.
DRUGMaintenance Therapy with Toripalimab and Capecitabine
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.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06277050
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