Nasopharyngeal Carcinoma Clinical Trials

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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Hunan Cancer Hospital
RECRUITING
Changsha
Third Xiangya Hospital, Central South University,
RECRUITING
Changsha
Xiangya Hospital of Central South University
RECRUITING
Changsha
The First People's Hospital of Chenzhou
RECRUITING
Chenzhou
The Central Hospital of Shaoyang
RECRUITING
Shaoyang
Yueyang Central Hospital
RECRUITING
Yueyang
Contact Information
Primary
Huai Liu, M.D.
liuhuai@hnca.org.cn
+8673189762230
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 26
Treatments
Experimental: LDRT and chemoimmunotherapy
Low-dose radiotherapy, chemotherapy, immunotherapy
Related Therapeutic Areas
Sponsors
Leads: Hunan Cancer Hospital

This content was sourced from clinicaltrials.gov