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Nasopharyngeal CarcinomaPhase 3NCT06383780

Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis.

A Phase 3 study testing GP combined with Tislelizumab and TPC combined with Tislelizumab in people with Nasopharyngeal Carcinoma, run by XIANG YANQUN at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
GP combined with Tislelizumab and TPC combined with Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
15 May 2024to 15 May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥ 18 years.
  • Histology or cytology confirmed nasopharyngeal carcinoma.
  • Metastatic nasopharyngeal carcinoma of bone that is not suitable for local or radical therapy.
  • 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.
  • 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).
  • Bone metastases may contain soft tissue components of osteolytic lesions.
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  • 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.
  • Expected survival ≥ 3 months.
  • According to the Eastern Cooperative Oncology Group (ECOG) criteria, the performance status score is 0 or 1.
  • 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.
  • Willing and able to comply with planned visits, treatment plans, laboratory tests, and other research procedures.

Who cannot join

  • Patients with osteo-oligometastatic nasopharyngeal carcinoma.
  • Previous history of severe hypersensitivity to any component of other monoclonal antibodies or tislelizumab monoclonal mab.
  • Patients have ≥ 1 metastatic organs or lymph node lesions that can be measured (assessed according to RECIST 1.1)
  • 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.
  • Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelling catheters, such as PleurX ® catheters, are allowed to participate.
  • 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.
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  • Poorly controlled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium> 12 mg/dL or corrected serum calcium higher than ULN)
  • 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).
  • 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.
  • 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).
  • 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.
  • Patients who have previously undergone allogeneic bone marrow transplantation or have previously undergone solid organ transplantation.
  • 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.
  • 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.
  • 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).
  • Presence of severe neurological or psychiatric disorders, including dementia and seizures.
  • Accompanied by NCI-CTCAE ≥ grade 2 peripheral neuropathy.
  • Pregnant or lactating female patients.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanqun Xiang contact

18666096623

xiangyq@syscc.org.cn

Guoying Liu contact

18127919832

liugy0109@163.com

China1 site, 1 recruiting

  • SunYat-senU

    Guangzhou, Guangdong, 510060

    Yanqun Xiang, MD, +86-18666096623, xiangyq@sysucc.org.cn

    Weixiong Xia, MD, +86-18520415699, xiawx@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Controlled, Multicenter Clinical Study Comparing the Efficacy of Pembrolizumab in Combination With Nab-TPC Regimen Versus the GP Regimen in the First-Line Treatment of Nasopharyngeal Carcinoma With Bone Metastases.

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.

Read the 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.

Being tested
GP combined with Tislelizumab, TPC combined with Tislelizumab
Keywords
Nasopharyngeal Carcinoma With Bone Metastasis, immunochemotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GP combined with TislelizumabDrug

    Gemcitabine combined with cisplatin regimen combined with Tislelizumab

  • TPC combined with TislelizumabDrug

    cisplatin, nab-paclitaxel and capecitabine regimen combined with Tislelizumab

Study groups in NCT06383780
Study groupRoleWhat they receive
GP combined with TislelizumabActive comparatorGemcitabine combined with cisplatin regimen combined with Tislelizumab
Receives: Drug: GP combined with Tislelizumab
TPC combined with TislelizumabExperimentalcisplatin, nab-paclitaxel and capecitabine regimen combined with Tislelizumab
Receives: Drug: TPC combined with Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year progression-free survival rate

    Measured: up to 3 years

Secondary outcomes (4)

  1. Overall survival

    Measured: up to 3 years

  2. incidence of adverse events

    safety

    Measured: up to 3 years

  3. rate of skeletal-related events

    Measured: up to 3 years

  4. Biomarker response (EBV-DNA, bone metabolic markers)

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start15 May 2024
  3. Primary completion15 May 2027 (estimated)
  4. Study completion15 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383780
Sponsor's protocol ID
SYSKY-2023-901-01
Status last verified
Jul 2024
First submitted
22 Apr 2024
Last updated
16 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The diagnosis, treatment regimen, toxicity and followup data will be shared once every year through email, phone or meeting.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP combined with Tislelizumab and TPC combined with Tislelizumab in people with Nasopharyngeal Carcinoma, run by XIANG YANQUN at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanqun Xiang (18666096623, xiangyq@syscc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year progression-free survival rate (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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