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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangxi Provincial Cancer Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy. If the patient refuses biopsy of metastatic lesions, those diagnosed with metastasis based on imaging evidence and clinical evidence can be enrolled.

Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence and metastases within 6 months after treatment of platinum-based chemoradiation.

Age ≥ 18 years and ≤ 75 years, both genders.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Disqualifiers

1. Those with a history of severe immediate allergy to any drugs used in this study; 2. Patients who have previously received anti-EGFR monoclonal antibodies (nitolizumab, cetuximab) and anti-PD-1 monoclonal antibodies.

Controlled type 1 diabetes

Hypothyroidism (if it can be controlled with hormone replacement therapy alone)

Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia)

Trial design

Treatments tested in this trial

  • Anti-PD1 antibody, nimotuzumab and capecitabine

Treatment groups

22 Participants
are divided into 1 treatment group