Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.

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

• The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;

• The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the efficacy reached more than stable disease;

• Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;

• ECOG PS score 0-2 points;

• Aged 18-70 years old;

• Major organ function met the following criteria (14 do not allow the use of any blood components and cell growth factor):

‣ Neutrophil ANC ≥ 2.0 × 10\^9/L; platelet count PLT ≥ 100 × 10\^9/L; hemoglobin HB ≥ 90 g/L;

⁃ Serum albumin ≥ 28 g/L;

⁃ Alanine aminotransferase ALT, aspartate aminotransferase AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;

⁃ Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL/min;

⁃ INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN;

• Life expectancy ≥ 12 weeks;

• The subject who voluntarily joins the study, sign informed consent, and coordinates with follow-up.

Locations
Other Locations
China
Fifth Affilliated Hospital of Sun Yat-sen University
RECRUITING
Zhuhai
Contact Information
Primary
Zhigang MD Liu, PhD
zhigangliu1983@hotmail.com
2528888
Backup
Zhigang MD Liu, PhD
liuzhg9@mail.sysu.edu.cn
2528888
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 28
Treatments
Experimental: Oligometastatic nasopharyngeal carcinoma
Patients included are going to receive radiotherapy, chemotherapy and immunotherapy. Radiotherapy includes IMRT and SBRT. IMRT is applied for primary sites and cervical lymph nodes,and SBRT following is applied for oligometastatic sites. PD-1 inhibitors: during the whole trial, intravenous, Q3W; Capecitabine: 650mg, po, bid, following the radiotherapy for a year.
Related Therapeutic Areas
Sponsors
Leads: Fifth Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov

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