Trial Title:
Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis.
NCT ID:
NCT06383780
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Neoplasm Metastasis
Nasopharyngeal Carcinoma
Tislelizumab
Conditions: Keywords:
Nasopharyngeal Carcinoma With Bone Metastasis
immunochemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Active Comparator:Drug:GP（Gemcitabine combined with cisplatin）regimen combined with
Tislelizumab Experimental:Drug：TPC（cisplatin, nab-paclitaxel and capecitabine）regimen
combined with Tislelizumab
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GP combined with Tislelizumab
Description:
Gemcitabine combined with cisplatin regimen combined with Tislelizumab
Arm group label:
GP combined with Tislelizumab
Intervention type:
Drug
Intervention name:
TPC combined with Tislelizumab
Description:
cisplatin, nab-paclitaxel and capecitabine regimen combined with Tislelizumab
Arm group label:
TPC combined with Tislelizumab
Summary:
This is a prospective, open-label phase III clinical trial evaluating the efficacy and
safety of the GP（Gemcitabine combined with cisplatin） regimen in combination with
Tislelizumab versus the TPC（cisplatin, nab-paclitaxel and capecitabine）regimen in
combination with Tislelizumab for the first-line treatment of Nasopharyngeal Carcinoma
patients With Bone Metastasis.
Detailed description:
This study aims to evaluate the efficacy and safety of the GP regimen combined with
Tislelizumab compared to the TPC regimen combined with Tislelizumab in the treatment of
advanced first-line bone metastatic nasopharyngeal carcinoma patients in high-risk
nasopharyngeal carcinoma areas through a prospective, open-label phase III clinical
trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age≥ 18 years.
2. Histology or cytology confirmed nasopharyngeal carcinoma.
3. Metastatic nasopharyngeal carcinoma of bone that is not suitable for local or
radical therapy.
4. Distant bone metastases confirmed by imaging (two images) or pathology (plus one
image) (AJCC 8th, stage IVB), except for isolated local invasion of the base bone of
the skull.
5. With or without metastases from other organs, but lesions may be non-measurable
distant organ metastases or lymph node lesions (as assessed by RECIST 1.1).
6. Bone metastases may contain soft tissue components of osteolytic lesions.
7. Patients have not previously received systemic therapy for advanced or metastatic
disease, and prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant
chemotherapy must have been completed more than 6 months prior to enrollment.
Previous radiotherapy or concurrent chemoradiotherapy should also be completed more
than 6 months prior to enrollment.
8. Expected survival ≥ 3 months.
9. According to the Eastern Cooperative Oncology Group (ECOG) criteria, the performance
status score is 0 or 1.
10. Good organ function:Hemoglobin > 8.0 g/dl; Absolute neutrophil count (ANC)
>1,500/mm3; Platelet count> 100,000/μl; Total bilirubin ≤ 1.5 times the upper limit
of normal (ULN); Alanine aminotransferase and glutamate aminotransferase < 2.5 ULN
(upper limit of normal), (alanine aminotransferase and aspartate aminotransferase <
5 ULN in patients with liver metastases), alkaline phosphatase< 4 ULN;Prothrombin
time (PT) international normalized ratio/prothrombin time (PTT) < 1.5 ULN, serum
muscle；Anhydride< 1.5ULN.
11. Willing and able to comply with planned visits, treatment plans, laboratory tests,
and other research procedures.
Exclusion Criteria:
1. Patients with osteo-oligometastatic nasopharyngeal carcinoma.
2. Previous history of severe hypersensitivity to any component of other monoclonal
antibodies or tislelizumab monoclonal mab.
3. Patients have ≥ 1 metastatic organs or lymph node lesions that can be measured
(assessed according to RECIST 1.1)
4. No definitive surgical and/or radiotherapy for spinal cord compression, or for
previously diagnosed and treated spinal cord compression, no evidence that the
disease was clinically stable for ≥ 2 weeks prior to enrollment.
5. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring
frequent drainage. Patients with indwelling catheters, such as PleurX ® catheters,
are allowed to participate.
6. Poorly controlled tumor-related pain. Patients requiring analgesic therapy must
receive a stable dose before enrolling in the study. Patients who are candidates for
palliative radiation therapy (e.g., bone metastases or metastases leading to nerve
damage) should be treated prior to enrollment Lesions are treated. Prior to
enrollment, if appropriate, consideration should be given to the need for further
growth that may result in functional deficits or intractable pain (e.g., For
example, asymptomatic metastases currently not associated with spinal cord
compression) are treated locally-regionally.
7. Poorly controlled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or
calcium> 12 mg/dL or corrected serum calcium higher than ULN)
8. Malignancy with malignancies other than nasopharyngeal carcinoma within 5 years
prior to enrollment, with negligible risk of metastasis or death (e.g., expected
5-year OS>90%) and expected radical results after treatment (e.g., adequately
treated cervix).
Localized cancer, basal or squamous cell skin cancer, localized prostate cancer
treated for radical purposes, surgical treatment for radical purposes Ductal
carcinoma in situ).
9. History of autoimmune diseases, including but not limited to myasthenia gravis,
myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis related to antiphospholipid
syndrome, Wegener's granuloma disease, Sjogren's syndrome, Guillain-Barré syndrome,
multiple sclerosis, vasculitis, or glomerulonephritis. Patients with
autoimmune-related hypothyroidism receiving stable dose thyroid hormone replacement
therapy were eligible to participate in this study. Patients with type 1 diabetes
who are controlled after receiving a stable insulin regimen are eligible to
participate in this study.
10. Receiving systemic immunostimulating drugs (including but not limited to interferon
or IL-2) within 4 weeks prior to enrollment or within 5 half-lives of the drug
(whichever is shorter).
11. Receiving systemic corticosteroids (> 10 mg/d prednisone equivalent) or other
systemic immunosuppressants (including but not limited to prednisone, dexamethasone,
cyclophosphamide, azathioprine, methotrexate, thalidomide and antibody) within 2
weeks prior to enrollment Tumor necrosis factor drugs [anti-TNF]). Topical, ocular,
intra-articular, intranasal, and inhaled corticosteroids are permitted. Patients
receiving acute low-dose systemic immunosuppressive agents (e.g., a single dose of
dexamethasone for nausea) can be considered after a comprehensive discussion to
decide whether to enroll in the study. Prophylactic steroids may be used in patients
requiring baseline and follow-up MRI tumor evaluation who have had a previous
allergic reaction to intravenous contrast.
12. Patients who have previously undergone allogeneic bone marrow transplantation or
have previously undergone solid organ transplantation.
13. History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organic pneumonia
(ie, bronchiolitis obliterans), history of idiopathic pneumonia or chest CT scan
showing evidence of active pneumonia at screening.
14. Active infection, including tuberculosis (clinical diagnosis includes clinical
history, physical examination and imaging findings, and TB examination according to
local medical practice), hepatitis B (known HBV surface antigen (HBsAg)), hepatitis
C, or human immunodeficiency virus (HIV antibody positive). Patients with previous
or cured HBV infection (defined as hepatitis B core antibody [anti-HBc] positive and
HbsAg-negative) are eligible to participate in this study only if they are HBV DNA
negative (HBV DNA ˂1000cps/ml). Patients with positive hepatitis C (HCV) antibodies
have only polymerase chain reaction (PCR) that is HCV RNA negative is eligible to
participate in this study.
15. Clinically significant underlying medical conditions (e.g., dyspnea, pneumonia,
pancreatitis, poorly controlled diabetes, active or poorly controlled infections,
drugs, or alcohol) that the investigator believes may affect study drug
administration and protocol adherence abuse, or mental illness).
16. Presence of severe neurological or psychiatric disorders, including dementia and
seizures.
17. Accompanied by NCI-CTCAE ≥ grade 2 peripheral neuropathy.
18. Pregnant or lactating female patients.
19. Major cardiovascular diseases, such as New York Heart Association heart disease
(grade II or higher, see Appendix 6), myocardial infarction within 3 months prior to
enrollment, unstable arrhythmias or unstable angina. Known to have coronary artery
disease, not satisfied Patients with standard congestive heart failure or left
ventricular ejection fraction < 50% must be treated with an optimized stable medical
regimen as determined by the treating physician, and if appropriate, a cardiologist.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SunYat-senU
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanqun Xiang, MD
Phone:
+86-18666096623
Email:
xiangyq@sysucc.org.cn
Contact backup:
Last name:
Weixiong Xia, MD
Phone:
+86-18520415699
Email:
xiawx@sysucc.org.cn
Start date:
May 15, 2024
Completion date:
May 15, 2029
Lead sponsor:
Agency:
XIANG YANQUN
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383780
