GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.