LDRT and Chemoimmunotherapy in NPC With Liver Metastasis

NCT06788002 | Recruiting Phase 2

• 2 other identifiers: KY2024528Z2023080
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

nasopharyngeal carcinoma; liver metastasis; low-dose radiotherapy; chemotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Intrahepatic progression-free survival (iPFS)

  Defined as the time from the start of therapy to the first progression in liver

  1 year

Secondary Outcomes (4)

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  2 year

• Objective response rate (ORR)

  18 weeks

• Incidence rate of adverse events (AEs)

  2 year

Study Arms (1)

LDRT and chemoimmunotherapy

EXPERIMENTAL

Low-dose radiotherapy, chemotherapy, immunotherapy

Other: Low-dose radiotherapy combine with chemoimmunotherapy

Interventions

Low-dose radiotherapy combine with chemoimmunotherapy OTHER

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)

LDRT and chemoimmunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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）

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (7)

Third Xiangya Hospital, Central South University,

Changsha, Hunan, 410000, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

The First People's Hospital of Chenzhou

Chenzhou, Hunan, 424300, China

RECRUITING

The Central Hospital of Shaoyang

Shaoyang, Hunan, 422000, China

RECRUITING

Yueyang Central Hospital

Yueyang, Hunan, 414020, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Huai Liu, M.D.

CONTACT

+8673189762230; liuhuai@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 22, 2025
• Study Start: January 14, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)