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New treatment option for Nasopharyngeal Cancinoma (NPC)
Official title LDRT and Chemoimmunotherapy in NPC With Liver Metastasis
ClinicalTrials.gov ID: NCT06788002
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy and toxicity of adding low-dose radiotherapy to chemoimmunotherapy as a first-line treatment for nasopharyngeal carcinoma patients with liver metastasis.
- Phase 2: a mid-size study of how well it works
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 70
You may be able to join if
- Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.
- Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III)
- Stage IVB (AJCC 8th edition staging)
- De novo nasopharyngeal carcinoma with liver metastasis, or patients who had received curative treatment (radical radiotherapy or radical radiotherapy...
- ECOG performance status: 0 or 1
You likely can't join if
- Patients with tumor recurrence at the primary site who have previously received radical radiotherapy.
- Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator.
- Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment.
- Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4).
- Patients with active autoimmune diseases or a history of autoimmune diseases with a risk of recurrence.
- Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
See the full eligibility criteria
Who can join
- Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.
- Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III)
- Stage IVB (AJCC 8th edition staging)
- De novo nasopharyngeal carcinoma with liver metastasis, or patients who had received curative treatment (radical radiotherapy or radical radiotherapy combined with chemotherapy) and developed liver metastasis more than...
- ECOG performance status: 0 or 1
- Must have at least one measurable lesion (assessed according to RECIST v1.1)
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelets ≥ 100 × 10\^9/L; hemoglobin ≥ 90 g/L.
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min.
- Serum total bilirubin ≤ 1.5 × ULN (patients with Gilbert's syndrome may be included if total bilirubin \< 3 × ULN); AST and ALT ≤ 5 × ULN （because of liver metastasis）
What rules you out
- Patients with tumor recurrence at the primary site who have previously received radical radiotherapy.
- Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator.
- Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment.
- Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4).
- Patients with active autoimmune diseases or a history of autoimmune diseases with a risk of recurrence.
- Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
- Conditions requiring systemic corticosteroid therapy (equivalent to \>10 mg/day of prednisone or similar medications) or other immunosuppressive therapy within ≤14 days prior to treatment.
- Uncontrolled diabetes or laboratory abnormalities ≥Grade 1 in potassium, sodium, or corrected calcium levels despite standard treatment, or ≥Grade 3 hypoalbuminemia within ≤14 days before treatment.
- History of the following diseases: interstitial lung disease, non-infectious pneumonitis, or uncontrolled diseases, including pulmonary fibrosis or acute lung disease.
- Severe chronic or active infections requiring systemic antibiotics, antifungals, or antivirals within ≤14 days before the first dose of the investigational drug (including tuberculosis infection).
- Known history of HIV infection.
- Untreated chronic hepatitis B patients or hepatitis B virus (HBV) carriers with HBV DNA ≥500 IU/mL, or active hepatitis C virus (HCV) carriers.
- Any major surgery requiring general anesthesia within ≤28 days prior to treatment.
- Previous allogeneic stem cell transplantation or organ transplantation.
- Any cardiovascular risk factors, including: cardiac chest pain that restricts daily instrumental activities ≤28 days before treatment. Symptomatic pulmonary embolism within ≤3 months before treatment. Acute myocardial...
- Evident bleeding tendencies or clinically significant bleeding symptoms ≤28 days prior to randomization, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis or retrograde...
- Known allergy to any component of the investigational drug or a history of severe hypersensitivity to other monoclonal antibodies.
- Peripheral neuropathy of Grade ≥2 as defined by NCI CTCAE v5.0.
- Administration of live vaccines within ≤4 weeks prior to treatment.
- Underlying medical conditions (including laboratory abnormalities) or alcohol/drug abuse or dependency that could impair drug administration, interpretation of drug toxicity, or adverse events (AEs), or could compromise...
- Pregnant or breastfeeding women.
- Other factors deemed by the investigator that could lead to the premature termination of the study, such as other severe illnesses, significant laboratory abnormalities, or family/social factors that could affect...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Chenzhou, Hunan, China
- Huaihua, Hunan, China
- Shaoyang, Hunan, China
- Yueyang, Hunan, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Chenzhou, Hunan, China; Huaihua, Hunan, China; Shaoyang, Hunan, China; Yueyang, Hunan, 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.