MedTrace Logo

Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT06259721 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-03-07

No results posted yet for this study

Summary

The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Anti-PD1 antibody, nimotuzumab and capecitabine

Combination phase Anti-PD1 monoclonal antibody: Choose one of the anti-PD-1 monoclonal antibody drugs reimbursed by medical insurance, toripalimab (240mg), camrelizumab (200mg), tislelizumab (200mg) or others; Intravenous infusion, every 3 weeks . Nimotuzumab:: In the first 6 cycles, 200 mg, intravenous infusion, every 1 week, and 400 mg is administered for the first time. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks Maintenance phase: Anti-PD1 monoclonal antibody: anti-PD-1 monoclonal antibody drugs, Intravenous infusion, every 3 weeks. Nimotuzumab treatment: 400 mg, intravenous infusion, every 3 weeks. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks； The duration of treatment is 1 year or until intolerable toxic reactions occur, or disease progresses, or the patient withdraws consent, or the investigator determines that the patient needs to withdraw from treatment.

Sponsors & Collaborators

  • Jiangxi Provincial Cancer Hospital

    lead OTHER

Principal Investigators

  • Jingao Li, MD · NHC Key Laboratory of Personalized Diagnosis and Treatment of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-02-10
Primary Completion
2026-02-09
Completion
2026-08-09

Countries

  • China

Study Locations

More Related Trials

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 NCT06259721 on ClinicalTrials.gov