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New treatment option for Nasopharyngeal Cancinoma (NPC)
Official title Adaptive Immunotherapy for Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT07154069
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily, being studied as a potential treatment for nasopharyngeal cancinoma (npc).
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
- 1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy.
- 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
- 18-65 years;
- Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);
- Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC)...
- ECOG performance status: 0-1;
- Adequate bone marrow function: white blood cell count \> 4 × 10⁹/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10⁹/L;
You likely can't join if
- T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;
- Disease progression after induction therapy;
- Hepatitis B surface antigen (HBsAg) positive with HBV DNA \>1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;
- Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
- Active tuberculosis;
- Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin...
See the full eligibility criteria
- 18-65 years;
- Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);
- Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;
- ECOG performance status: 0-1;
- Adequate bone marrow function: white blood cell count \> 4 × 10⁹/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10⁹/L;
- Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine...
- Normal thyroid function, amylase, lipase, pituitary function;
- Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy;
- Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
- Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment.
- T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;
- Disease progression after induction therapy;
- Hepatitis B surface antigen (HBsAg) positive with HBV DNA \>1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;
- Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
- Active tuberculosis;
- Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis...
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year;
- Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. people using inhaled or topical corticosteroids are eligible;
- Uncontrolled cardiac disease;
- Pregnant or lactating women;
- History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma;
- Known allergy to macromolecular protein preparations or any component of toripalimab;
- Active infection requiring systemic treatment within one week prior to enrollment;
- Administration of a live vaccine within 30 days before the first dose of toripalimab;
- History of organ transplantation;
- Contraindications to MRI examination, which would prevent the completion of required imaging;
- Any other condition deemed by the investigators to potentially compromise patient safety or compliance.
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.