Actively Recruiting
Low-dose Radiotherapy and Chemoimmunotherapy in Nasopharyngeal Carcinoma With Liver Metastasis
Led by Hunan Cancer Hospital · Updated on 2026-04-02
26
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of low-dose radiotherapy to chemoimmunotherapy as a first treatment approach for patients with nasopharyngeal carcinoma who have liver metastasis. This Phase 2 study aims to assess the effectiveness and side effects of this combination treatment in controlling cancer progression within the liver. The treatment involves giving low-dose radiotherapy to the liver metastases at 1.4 Gy daily for 5 days before starting chemoimmunotherapy. The chemoimmunotherapy includes gemcitabine and cisplatin chemotherapy alongside penpulimab immunotherapy. Participants receive these treatments in a combined regimen as the experimental group. Participants will be monitored for tumor response and survival outcomes, with evaluations including imaging to measure tumor lesions and laboratory tests to assess blood counts and organ function. The main outcome measured is progression-free survival within the liver at one year. Secondary outcomes include overall progression-free survival, overall survival up to two years, response rates at 18 weeks, and tracking of any adverse effects. The study will last until mid-2027, with ongoing safety and efficacy assessments.
CONDITIONS
Brief 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 disease according to AJCC 8th edition
- Newly diagnosed with liver metastasis or developed liver metastasis more than 6 months after prior curative treatment
- ECOG performance status of 0 or 1
- At least one measurable lesion according to RECIST v1.1
- Adequate blood counts: ANC ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L
- Coagulation within normal limits: INR/PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN
- Kidney function: serum creatinine ≤ 1.5 × ULN or eGFR ≥ 60 mL/min
- Liver function: total bilirubin ≤ 1.5 × ULN (or < 3 × ULN if Gilbert's syndrome), AST and ALT ≤ 5 × ULN due to liver metastasis
You will not qualify if you...
- Tumor recurrence at primary site after radical radiotherapy
- Tumor involving major blood vessels with high bleeding risk
- Systemic anticancer therapy within 28 days before study treatment
- Previous immune checkpoint inhibitor therapy
- Active or history of autoimmune diseases with risk of recurrence
- Other malignancies except cured basal cell carcinoma or carcinoma in situ of the cervix
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive therapy within 14 days
- Uncontrolled diabetes or significant lab abnormalities within 14 days before treatment
- History of interstitial lung disease, pneumonitis, pulmonary fibrosis, or acute lung disease
- Severe infections requiring systemic treatment within 14 days before first dose
- Known HIV infection
- Untreated hepatitis B or active hepatitis C infection
- Major surgery requiring general anesthesia within 28 days
- Prior allogeneic stem cell or organ transplantation
- Significant cardiovascular risks or recent heart events within specified timeframes
- Bleeding disorders or significant bleeding within 28 days before randomization
- Allergy or severe hypersensitivity to study drug components or monoclonal antibodies
- Peripheral neuropathy grade 2 or higher
- Live vaccine administration within 4 weeks before treatment
- Medical conditions, substance abuse, or other factors that impair study compliance
- Pregnant or breastfeeding women
- Other investigator-assessed factors risking participant safety or study data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days of radiotherapy plus chemotherapy and immunotherapy cycles as scheduled
Participants receive low-dose radiotherapy to the liver metastasis followed by chemoimmunotherapy with gemcitabine, cisplatin, and penpulimab.
Radiotherapy for 5 consecutive days and chemotherapy/immunotherapy infusions on specified days within each treatment cycle
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.
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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