LDRT and Chemoimmunotherapy in NPC With Liver Metastasis (NCT06788002) | Clinical Trial Compass
RecruitingPhase 2
LDRT and Chemoimmunotherapy in NPC With Liver Metastasis
China26 participantsStarted 2025-01-14
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 6 months after treatment completion.
. ECOG performance status: 0 or 1
. Must have at least one measurable lesion (assessed according to RECIST v1.1)
. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
Exclusion criteria
. Patients with tumor recurrence at the primary site who have previously received radical radiotherapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses low-dose radiation therapy (LDRT) directed at the liver combined with chemoimmunotherapy for NPC that has spread to the liver — how does adding that liver-targeted radiation compare to what I'd receive with standard chemoimmunotherapy alone?
2Since this is a Phase 2 trial, the researchers are still building evidence on how well this approach works and what the side effects look like — what does that mean for my personal risk compared to already-established treatment options?
3The trial's main goal is to measure how long the cancer inside the liver can be kept under control (intrahepatic progression-free survival) — does that mean it may not tell us yet whether this approach helps people live longer overall, and how should I weigh that when deciding?
4Combining radiation to the liver with chemotherapy and immunotherapy involves multiple treatments at once — what kinds of side effects should I be prepared for, especially given the liver is being targeted directly?
5Are there standard treatments for NPC with liver metastasis that my care team would recommend trying first, or is this trial something worth discussing as a first-line option given my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.