Actively Recruiting
LDRT and Chemoimmunotherapy in NPC With Liver Metastasis
Led by Hunan Cancer Hospital · Updated on 2026-04-02
26
Participants Needed
7
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LDRT and Chemoimmunotherapy in NPC With Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, male or non-pregnant female
- Histologically confirmed nonkeratinizing nasopharyngeal carcinoma (WHO II or III)
- Stage IVB according to AJCC 8th edition
- Newly diagnosed or previously treated nasopharyngeal carcinoma with liver metastasis
- ECOG performance status of 0 or 1
- At least one measurable lesion by RECIST v1.1 criteria
- Absolute neutrophil count ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L; hemoglobin ≥ 90 g/L
- INR or prothrombin time ≤ 1.5 × upper limit of normal; activated partial thromboplastin time ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate ≥ 60 mL/min
- Serum total bilirubin ≤ 1.5 × ULN (including Gilbert's syndrome if < 3 × ULN); AST and ALT ≤ 5 × ULN due to liver metastasis
You will not qualify if you...
- Tumor recurrence at primary site after prior radical radiotherapy
- Tumor invasion of major blood vessels with high bleeding risk
- Systemic anticancer therapy within 28 days before study treatment
- Previous treatment with immune checkpoint inhibitors such as PD-1/PD-L1 or CTLA-4
- Active or history of autoimmune diseases with risk of recurrence
- Known other malignancies except cured basal cell carcinoma or cervical carcinoma in situ
- Need for systemic corticosteroids >10 mg/day prednisone equivalent or immunosuppressive therapy within 14 days before treatment
- Uncontrolled diabetes or significant electrolyte abnormalities despite treatment
- History of interstitial lung disease, pneumonitis, pulmonary fibrosis, or acute lung disease
- Severe active infections requiring systemic treatment within 14 days before first study drug dose
- Known HIV infection
- Untreated chronic hepatitis B or active hepatitis C with specific viral loads
- Major surgery under general anesthesia within 28 days prior to treatment
- Previous allogeneic stem cell or organ transplantation
- Recent serious cardiovascular events or conditions within specified timeframes
- Significant bleeding tendencies or symptoms within 28 days prior to randomization
- Allergy to investigational drug components or severe monoclonal antibody hypersensitivity
- Peripheral neuropathy Grade 2 or higher
- Administration of live vaccines within 4 weeks prior to treatment
- Medical conditions or substance abuse impacting drug administration or study compliance
- Pregnant or breastfeeding women
- Other investigator-determined factors affecting safety or data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Third Xiangya Hospital, Central South University,
Changsha, Hunan, China, 410000
Actively Recruiting
2
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
3
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
4
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
5
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China, 424300
Actively Recruiting
6
The Central Hospital of Shaoyang
Shaoyang, Hunan, China, 422000
Actively Recruiting
7
Yueyang Central Hospital
Yueyang, Hunan, China, 414020
Actively Recruiting
Research Team
H
Huai Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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