Nasopharyngeal Cancinoma (NPC)Phase 2LightNCT06788002
LDRT and Chemoimmunotherapy in NPC With Liver Metastasis
A Phase 2 study testing Low-dose radiotherapy combine with chemoimmunotherapy in people with Nasopharyngeal Cancinoma (NPC), run by Hunan Cancer Hospital at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Low-dose radiotherapy combine with chemoimmunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 8 sitesChina
- Study dates
- 14 Jan 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 6 months after treatment completion.
- ECOG performance status: 0 or 1
- Must have at least one measurable lesion (assessed according to RECIST v1.1)
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- 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）
Who cannot join
- 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).
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- 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 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.
- 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.
- 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 study compliance or execution.
- 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 participant safety or the collection of study data.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Third Xiangya Hospital, Central South University,
Changsha, Hunan, 410000
Qingnan Tang, 8615692028619, qingnantang@qq.com
Xi Pan
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Qin Zhou, zhouqin5796@csu.edu.cn
Qin Zhou
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Huai Liu, +8673189762230, liuhuai@hnca.org.cn
Huai Liu, M.D.
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Hui Wang, M.D., +8673189762230, wanghui@hnca.org.cn
- Recruiting
The First People's Hospital of Chenzhou
Chenzhou, Hunan, 424300
Qiyuan Zhou, 8618175547107, czyyflgcp@163.com
Jinyong Tang
- Recruiting
Hunan University of Medicine General Hospital
Huaihua, Hunan
Hanbing Wu, +8618774797921, 466875142@qq.com
- Recruiting
The Central Hospital of Shaoyang
Shaoyang, Hunan, 422000
Xinfu Liu, 8615807397520, xinfuliudoc@163.com
Xinfu Liu
- Recruiting
Yueyang Central Hospital
Yueyang, Hunan, 414020
Jie Weng, 8613975070672, 3173720582@qq.com
Jie Weng
About this study
Official title: Low-dose Radiotherapy and Chemoimmunotherapy in Nasopharyngeal Carcinoma With Liver Metastasis
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.
Read the detailed description
Low-dose radiotherapy to the liver metastasis. Chemotherapy: gemcitabine and cisplatin Immunotherapy: penpulimab
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Low-dose radiotherapy combine with chemoimmunotherapy
- Keywords
- nasopharyngeal carcinoma, liver metastasis, low-dose radiotherapy, chemotherapy, immunotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose radiotherapy combine with chemoimmunotherapyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| LDRT and chemoimmunotherapy | Experimental | Low-dose radiotherapy, chemotherapy, immunotherapy Receives: Other: Low-dose radiotherapy combine with chemoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahepatic progression-free survival (iPFS)
Defined as the time from the start of therapy to the first progression in liver
Measured: 1 year
Secondary outcomes (4)
Progression-free survival (PFS)
Defined as the time from the start of therapy to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Measured: 1 year
Overall survival (OS)
Defined as the time from the start of therapy to death from any cause or censored at the date of last follow-up.
Measured: 2 year
Objective response rate (ORR)
Defined as the proportion of patients achieving complete response (CR) or partial response (PR) in all patients. According to RECIST 1.1 evaluation criteria, physicians use the efficacy evaluation record as the determination criteria
Measured: 18 weeks
Incidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated by CTCAE v5.0.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start14 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HuaiLiu, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788002
- Sponsor's protocol ID
- KY2024528
- Other IDs
- Z2023080
- Acronym
- Light
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the policy of hospital
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Radiotherapy and Chemoimmunotherapy in Nasopharyngeal Carcinoma With Liver Metastasis
- ClinicalTrials.gov ID
- NCT06788002
- Acronym / sponsor ID
- Light / KY2024528
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- nasopharyngeal carcinoma, liver metastasis, low-dose radiotherapy, chemotherapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low-dose radiotherapy to the liver metastasis. Chemotherapy: gemcitabine and cisplatin Immunotherapy: penpulimab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDRT and chemoimmunotherapy | Experimental | Other: Low-dose radiotherapy combine with chemoimmunotherapyLow-dose radiotherapy, chemotherapy, immunotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose radiotherapy combine with chemoimmunotherapyRadiation: 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) | Other | LDRT and chemoimmunotherapy |
Primary outcome
Intrahepatic progression-free survival (iPFS)
Time frame: 1 year
Defined as the time from the start of therapy to the first progression in liver
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 year
Objective response rate (ORR)
Time frame: 18 weeks
Incidence rate of adverse events (AEs)
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Because of the policy of hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose radiotherapy combine with chemoimmunotherapy in people with Nasopharyngeal Cancinoma (NPC), run by Hunan Cancer Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huai Liu, M.D. (+8673189762230, liuhuai@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic progression-free survival (iPFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.