Ann: Clinical Trial Supply Agreement with Merck KGaA and Pfizer, page-166

Hi Dave,

The trial is gastric cancer that has been detected early (most likely only stage 1 cancers). The usual treatment for early stage gastric cancers is a short course of chemo followed by surgical resection. Incidentally, I saw a tv segment of someone with stage 1 adenocarcinoma of the oesophagus (lower section) who was lucky enough to go through this process. There's an initial course of chemo to shrink the tumour then they cut out about a foot of oesophagus and stomach. (They cut out more than they need to ensure they don't miss any tumour cells.) They then staple the lower half of the stomach to what remains of the oesophagus (not much). It was pretty brutal with life long side effects when eating but better than the alternative which results in a far more brutal short lived soul destroying outcome.

It will be interesting to hear how they determine CR. Given these patients are eligible for surgery, I expect they will proceed with the surgery then examine the removed gastro-oesophageal tissue under a microscope (as they would for a biopsy) which would certainly be one way to give a definitive "it was/was not a complete response". OS wouldn't be an end point as you would expect the patients to be cancer free after the surgery and to go on and live a long and somewhat happy life.