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New treatment option for Nasopharyngeal Carcinoma
Official title Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT05342792
What this study is testing
What is PD-1 antibody?
PD-1 antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
Also referred to as Tislelizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age at diagnosis: 18 \~ 65 years old;
- Pathologically confirmed primary nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
- Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) was diagnosed according to...
- Induction and concurrent chemoradiotherapy with the recommended regimen have been completed;
- ECOG score: 0 \~ 1 points (Appendix II);
You likely can't join if
- Positive hepatitis B surface antigen and hepatitis B virus quantification \> 1 × 1000 copies/ml, or positive anti-hepatitis C virus antibody;
- Positive anti-HIV antibody or diagnosis of acquired immunodeficiency syndrome (i.e., AIDS);
- Conditions such as dysphagia, chronic diarrhea, or bowel obstruction that would interfere with oral medication.
- Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal or antiviral therapy before...
- Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis...
- Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year;
See the full eligibility criteria
- Age at diagnosis: 18 \~ 65 years old;
- Pathologically confirmed primary nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
- Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) was diagnosed according to the American Joint Committee on Cancer/Union for International Cancer...
- Induction and concurrent chemoradiotherapy with the recommended regimen have been completed;
- ECOG score: 0 \~ 1 points (Appendix II);
- It is recommended to initiate adjuvant therapy within 1 month after the completion of the last radiotherapy treatment, no later than 6 weeks;
- Normal bone marrow function: white blood cell count \> 4 × 109/L, hemoglobin concentration \> 90 g/L, platelet count \> 100 × 109/L;
- Normal liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of normal; aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 times the upper limit of normal; alkaline phosphatase ≤ 2.5 times...
- people must sign the informed consent form, and must be willing and able to comply with the visits, treatment regimen, laboratory tests and other requirements specified in the study protocol;
- Female people of childbearing potential and male people with partners of childbearing potential must agree to use reliable contraception (e.g., condoms, regular contraceptives as directed) from screening through 1 year...
- Positive hepatitis B surface antigen and hepatitis B virus quantification \> 1 × 1000 copies/ml, or positive anti-hepatitis C virus antibody;
- Positive anti-HIV antibody or diagnosis of acquired immunodeficiency syndrome (i.e., AIDS);
- Conditions such as dysphagia, chronic diarrhea, or bowel obstruction that would interfere with oral medication.
- Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal or antiviral therapy before randomization, including but not limited to tuberculosis infection
- Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchiectasis)...
- Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year;
- Definite clinical evidence of persistent local disease or distant metastasis after chemoradiotherapy;
- Systemic hormonal or other immunosuppressive therapy with an equivalent dose of \> 10 mg prednisone/day within 28 days prior to informed consent. people with systemic sex hormone doses ≤ 10 mg prednisone/day or...
- Uncontrolled heart disease, such as: 1) heart failure, NYHA level ≥ 2; 2) unstable angina; 3) history of myocardial infarction in the past year; 4) supraventricular arrhythmia or ventricular arrhythmia requiring...
- Pregnant or lactating women (pregnancy test should be considered for sexually active women of childbearing age);
- Previous or current other malignancy other than adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma;
- Receipt of live vaccines within 30 days prior to the first course of tislelizumab;
- History of organ transplantation;
- Other conditions that may jeopardize patient safety or compliance as assessed by the investigator, such as serious illness (including psychiatric disorders) requiring prompt treatment, severely abnormal test results...
- Patients who received surgical treatment, biological therapy, or immunotherapy during or before radiotherapy;
- Patients who are receiving or are likely to receive other chemotherapy, biological therapy, or immunotherapy History of severe hypersensitivity to other monoclonal antibodies;
- Chemotherapy or surgery (except diagnostic) of the primary tumor or lymph nodes before standard treatment.
- History of radiation therapy prior to standard therapy (except for non-melanoma skin cancer).
- Patients who are known to be intolerable or sensitive to any therapeutic agents.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.