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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

LDRT and Chemoimmunotherapy in NPC With Liver Metastasis

Low-dose Radiotherapy and Chemoimmunotherapy in Nasopharyngeal Carcinoma With Liver Metastasis

LDRT and Chemoimmunotherapy in NPC With Liver Metastasis (NCT06788002) is a Phase 2 interventional studying Nasopharyngeal Cancinoma (NPC), sponsored by Hunan Cancer Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Nasopharyngeal Cancinoma (NPC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 26 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years and ≤ 70 years, male or non-pregnant female. 2. diagnosed by tissue sample (biopsy-confirmed) with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III) 3. Stage IVB (AJCC 8th edition staging) 4. 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. 5. ECOG performance status: 0 or 1 6. Must have at least one measurable lesion (assessed according to RECIST v1.1) 7. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelet count at least 100 × 10\^9/L; blood count (hemoglobin) at least 90 g/L. 8. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN 9. Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min. 10. 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) Who Should NOT Join This Trial: 1. Patients with tumor recurrence at the primary site who have previously received radical radiotherapy. 2. Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator. 3. Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment. 4. Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4). 5. Patients with active autoimmune conditions (where your immune system attacks your own body)s or a history of autoimmune conditions (where your immune system attacks your own body)s with a risk of recurrence. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 70 years, male or non-pregnant female. 2. Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III) 3. Stage IVB (AJCC 8th edition staging) 4. 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. 5. ECOG performance status: 0 or 1 6. Must have at least one measurable lesion (assessed according to RECIST v1.1) 7. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelets ≥ 100 × 10\^9/L; hemoglobin ≥ 90 g/L. 8. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN 9. Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min. 10. 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) Exclusion Criteria: 1. Patients with tumor recurrence at the primary site who have previously received radical radiotherapy. 2. Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator. 3. Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment. 4. Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4). 5. Patients with active autoimmune diseases or a history of autoimmune diseases with a risk of recurrence. 6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix). 7. 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. 8. 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. 9. History of the following diseases: interstitial lung disease, non-infectious pneumonitis, or uncontrolled diseases, including pulmonary fibrosis or acute lung disease. 10. 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). 11. Known history of HIV infection. 12. Untreated chronic hepatitis B patients or hepatitis B virus (HBV) carriers with HBV DNA ≥500 IU/mL, or active hepatitis C virus (HCV) carriers. 13. Any major surgery requiring general anesthesia within ≤28 days prior to treatment. 14. Previous allogeneic stem cell transplantation or organ transplantation. 15. 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 infarction within ≤6 months before treatment. History of heart failure meeting New York Heart Association (NYHA) Class III or IV within ≤6 months before treatment. Grade ≥2 ventricular arrhythmias within ≤6 months before treatment. History of cerebrovascular accident within ≤6 months before the first dose of the investigational drug. 16. 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 blood-stained nasal discharge), and persistent bleeding disorders or coagulopathy. 17. Known allergy to any component of the investigational drug or a history of severe hypersensitivity to other monoclonal antibodies. 18. Peripheral neuropathy of Grade ≥2 as defined by NCI CTCAE v5.0. 19. Administration of live vaccines within ≤4 weeks prior to treatment. 20. 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 study compliance or execution. 21. Pregnant or breastfeeding women. 22. 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 participant safety or the collection of study data.

Treatments Being Tested

OTHER

Low-dose radiotherapy combine with chemoimmunotherapy

Radiation: 1.4Gy for 5 days to the liver metastasis before chemoimmunotherapy. Chemoimmunotherapy: gemcitabine(1000mg per square meter on days 1,8) , cisplatin (80mg per square meter on day 1), penpulimab (200mg, day1)

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Third Xiangya Hospital, Central South University,
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
The Central Hospital of Shaoyang
Shaoyang, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06788002), the sponsor (Hunan Cancer Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06788002 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06788002?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06788002?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06788002. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06788002. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.