Tumor Responses Clinical Trial
Official title:
Dose Escalation of Lobaplatin Concurrent With Intensity-modulated Radiotherapy for the Treatment of Stage III-IVb Nasopharyngeal Carcinoma: A Phase I Clinical Trial in an Asian Population
Nasopharyngeal carcinoma (NPC) is a common malignant tumor in Southern China area, which is
characterized by obvious regional characteristics and "Guangdong cancer". Radiotherapy is the
main treatment for locally advanced nasopharyngeal carcinoma. In recent years, chemotherapy
has improved the short-term and long-term survival of patients with locally advanced
nasopharyngeal carcinoma.
Lobaplatin is the third generation platinum anticancer drugs, mechanism of action and
traditional cisplatin is similar, mainly formed by the Pt-GG and Pt-AG chain cross connect,
replication and transcription process blocks of deoxyribonucleic acid(DNA), thereby
interfering with tumor cell cycle. The damage of DNA induced by lobaplatin can influence the
expression of tumor cell specific genes. Due to the different structure of lobaplatin and no
cross resistance to cisplatin in the study showed that, compared with cisplatin with
gastrointestinal reaction more mild, and no cisplatin common liver and kidney toxicity,
neurotoxicity and ototoxicity, in some tumors have a better adaptability; but compared with
cisplatin had more severe bone marrow suppression this, offset some of the advantages of
lobaplatin in a certain extent. At present, the clinical indications for the treatment of
such diseases include head and neck cancer, breast cancer, gastrointestinal cancer,
gynecologic malignant tumor and non small cell lung cancer. Tian Ying confirmed that
lobaplatin has obvious cytotoxic effect on nasopharyngeal carcinoma cells, in a concentration
dependent manner, the mechanism for the dual role, namely block at lower concentration of
cells in G2 phase and induce apoptosis at higher concentration, provide the possibility for
clinical treatment of nasopharyngeal carcinoma for lobaplatin; there are a number of clinical
study confirmed that lobaplatin chemoradiotherapy for locally advanced nasopharyngeal
carcinoma with cisplatin approximation. But at present, there is no report on the dose and
tolerability of concurrent radiotherapy for nasopharyngeal carcinoma.
Therefore, a dose escalation trial was conducted to determine maximum tolerated dose of
lobaplat in as a single agent combined with concurrent intensity-modulated radiotherapy in a
Chinese population with locoregionally advanced NPC.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03275376 -
Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma
|
Phase 2 |