Trial Title:
Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
NCT ID:
NCT06277050
Condition:
Nasopharyngeal Carcinoma
High-Risk Cancer
Maintenance Therapy
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Maintenance Therapy with Toripalimab and Capecitabine
Description:
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.
Arm group label:
Maintenance Therapy with Toripalimab and Capecitabine
Intervention type:
Drug
Intervention name:
Maintenance Therapy with Capecitabine
Description:
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.
Arm group label:
Maintenance Therapy with Capecitabine alone
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).
Detailed description:
The study randomly divided these three types of high-risk nasopharyngeal carcinoma into
two groups. The experimental group received maintenance therapy with toripalimab and
capecitabine, while the control group received maintenance therapy with capecitabine
alone. The maintenance treatment period of the two groups was 1 year.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically confirmed nasopharyngeal carcinoma;
2. 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.
3.18-70 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.
7. 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 Criteria:
1. Recurrent or distant metastatic nasopharyngeal carcinoma.
2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical
carcinoma in situ) within the last 5 years.
3. Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including
investigational agents for NPC
4. Has received prior therapy with an anti-PD-1 mab.
5. 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:
1. Controlled Type I diabetes
2. Hypothyroidism (provided it is managed with hormone replacement therapy only)
3. Controlled celiac disease
4. 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.
6. 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:
1. Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with
minimal systemic absorption
3. 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)。
7. With history of interstitial lung disease, non-infectious pneumonitis or
uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
8. With severe chronic or active infections requiring systemic antibacterial,
antifungal or antiviral therapy, including tuberculosis infection, etc.
1. 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.
2. Received therapeutic oral or intravenous antibiotics within 2 weeks before
start of the study.
9. A known history of HIV infection
10. 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.
11. Any major surgical procedure requiring general anaesthesia ≤28 days before start of
study。
12. Prior allogeneic stem cell transplantation or organ transplantation.
13. Any of the following cardiovascular risk factors:
1. Cardiac chest pain, defined as moderate pain that limits instrumental
activities of daily living, ≤28 days before start of study
2. Pulmonary embolism ≤28 days before start of study
3. Any history of acute myocardial infarction ≤6 months before start of study
4. Any history of heart failure meeting New York Heart Association (NYHA)
Classification III or IV ≤6 months before start of study
5. Any event of ventricular arrhythmia ≥Grade 2 in severity ≤6 months before start
of study
6. Any history of cerebrovascular accident ≤6 months before start of study
7. Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure
≥100 mmHg despite anti-hypertension medications ≤28 days before start of study
8. Any episode of syncope or seizure ≤28 days before start of study.
14. A history of severe hypersensitivity reactions to toripalimab, capecitabine and/or
any of its excipients.
15. Has received any herbal medicine used to control cancer within 14 days of the start
of study
16. 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)
17. Concurrent participation in another therapeutic clinical study
18. Emotional disturbance or mental illness
19. Refusal or inability to sign informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ganzhou Cancer Hospital
Address:
City:
Ganzhou
Zip:
341000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wei Wu, M.D.
Investigator:
Last name:
Wei Wu, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Songhuan Lin, M.D.
Email:
Sub-Investigator
Facility:
Name:
First Affiliated hospital of Gannan Medical University
Address:
City:
Guangzhou
Zip:
341000
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingjun Xu, MD
Investigator:
Last name:
Mingjun Xu, MD
Email:
Principal Investigator
Investigator:
Last name:
Renwang Chen, PhD
Email:
Sub-Investigator
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Tianzhu Lu
Phone:
8615270186250
Email:
lutianzhu2008@163.com
Investigator:
Last name:
Jingao Li, PhD
Email:
Principal Investigator
Investigator:
Last name:
Xiaochang Gong, MD
Email:
Sub-Investigator
Start date:
March 7, 2024
Completion date:
February 20, 2030
Lead sponsor:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Source:
Jiangxi Provincial Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277050
