Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Relapsed After a Cisplatin Based Treatment) Clinical Trial
Official title:
A Phase 2 Trial of Oxaliplatin and Sorafenib Combination in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Relapsed After a Cisplatin Based Treatment
In Spain, the gastric carcinoma is the 5th most frequent malignant tumor in women and the
6th in men, and represents the 3rd cause of cancer-related deaths amongst women and the 4th
amongst men. The average of 5-year survival rate in Spain is under 30%. The main reason of
it is that, despite carrying out an adjuvant treatment, more than the 50% will present
relapsed disease.
Sorafenib has been the first RAF inhibitor, both of RAF-1 and B-rRAF and its b-RAF variant
V600E. Moreover, it has shown its ability to inhibit other tyrosin-quinase receptors as
VEGFR 2 and 3, c-kit, Flt-3 or PDGFR. Its activity has been clearly proven in clear cell
renal carcinoma.
The mechanism by which Sorafenib seems to act is not because of the existence of a mutation
of RAS or RAF, but because as there is a VHL shortage the HIP produces a VEGF, bFGF or TGF
overexpression that produces in turn a hyper-stimulation on the RAF/ERK/MEK pathway.
The RAF/MEK/ERK pathway and angiogenesis seem to be clearly involved in the gastric
carcinoma tumorigenesis and progression. Because of that, it seems interesting to associate
Sorafenib to an oxaliplatin-based chemotherapy, which has shown its effectiveness in
relapsed patients after receiving cisplatin-based schemes. Moreover, there is a phase 1
trial confirming the tolerance of the oxaliplatin and Sorafenib association, describing
partial responses amongst gastric cancer patients previously treated with cisplatin.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment