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PD-1 Inhibitors Plus Chemoradiotherapy for Metastatic Nasopharyngeal Carcinoma: an Open-label Single-arm, Phase II Trial

NCT05520814 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-21

No results posted yet for this study

Summary

programmed cell death-1 (PD-1) inhibitors has been recommended as the first-line treatment for recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), but progression-free survival (PFS) and overall survival (OS) was still unsatisfactory. Basic studies have already confirmed PD-1 inhibitors had concurrent synergistic effect with chemotherapy and radiotherapy. Few studies concerned about the treatment pattern for concurrent PD-1 inhibitors combination with chemoradiation for R/M NPC. There was still much uncertainties about the timing, fraction dose and total dose for PD-1 inhibitors combination with radiation. Therefore, we aimed to explore the substantial effect and toxicity of this new pattern for R/M NPC.

Conditions

  • Nasopharyngeal Carcinoma
  • PD-1 Inhibitors
  • Chemoradiotherapy

Interventions

DRUG

PD-1 inhibitors

treprizumab injection 240mg / carrilizumab injection 200mg / Tirelizumab injection 200mg \* q21d (until the disease progresses, intolerable toxicity or the investigator / subject decides to withdraw from the study, and the duration of PD-1 inhibitor is not more than 96 weeks)

RADIATION

chemoradiotherapy

Chemotherapy： 1. GP: gemcitabine 1g/m2 D1, 8 Cisplatin 80 mg/m2 d1 \* Treatment courses every 3 weeks 2. Cisplatin 80mg/m2 d1 or carboplatin area under the curve 5mg/ml/min \* Treatment courses every 3 weeks Radiotherapy： All the metastatic lesions received radiation dose from 30 to 60Gy according to different metastatic sites.

Sponsors & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05520814 on ClinicalTrials.gov