GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma

Stage IV Nasopharyngeal Carcinoma Clinical Trial

Official title: Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Status Recruiting

Clinical Trial Summary

Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in Southern China and South Asia. After radiotherapy, some patients with nasopharyngeal carcinoma still had distant metastasis. In recent years, some chemotherapeutic agents, such as gemcitabine, cisplatin, were used to treat patients with advanced nasopharyngeal carcinoma, including those with local recurrence and distant metastases, with a certain short-term effect. However, chemotherapy alone is still not ideal for effectively improving the prognosis of patients with advanced nasopharyngeal carcinoma. Therefore, it is necessary to develop more-effective adjuvant therapies.

CIK cells (cytokine induced killer cells, CIK) are a population of heterogeneous cells generated by the in vitro amplification of mononuclear cells in peripheral blood. The cells are co-induced with multiple cytokines; the lymphocytes with co-expression of CD3+CD56+ have the strongest anti-tumor effect. Because of their non-MHC restricted tumor killing activity, CIK cells have a powerful anti-tumor effect both in vitro and in vivo, which spans a broad anti-tumor spectrum.

In this study, the patients with post-radiotherapy distant metastasis of NPC will be treated with autologous CIK cells in combination with Gemcitabine plus Cisplatin regimen chemotherapy(GC). The purpose of this study is to observe and evaluate the toxic side effects and the short- and long-term efficacy of CIK used in combination with GC chemotherapy to treat NPC in patients with distant metastasis after radiotherapy. Patients and Methods: 40 patients with distant metastasis after radiotherapy will accept 4 cycles chemotherapy of Gemcitabine plus cisplatin regimen and then are randomized divided into 2 groups. The 20 patients in GC+CIK group will be treated with maintaining therapy of adoptive autologous CIK cell transfusion sequentially; the other 20 patients will be followed-up only without CIK cells treatment. The safety of chemotherapy and CIK cells transfusion and the tumor regression status will be observed. The early response and long-term efficacy of two groups patients who accept GC chemotherapy or GC +CIK bio-therapy will be investigated.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Neoplasms
• Stage IV Nasopharyngeal Carcinoma

• NCT number: NCT01655628
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Jian-jun Li, M.D. Ph.D
• Phone: 86-2087343381
• Email: lijj@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2012
• Completion date: December 2014