M6620 Plus Standard Treatment in Oesophageal and Other Cancer

INCLUSION CRITERIA

For Stage A1:

• Histologically confirmed adenocarcinoma or squamous cell carcinoma of the oesophagus (not including cervical oesophagus)
• Tumor length 15cm or less
• Any stage of disease that is unsuitable for radical CRT or surgery but suitable for palliative RT
• Baseline investigations available: staging CT scan (within 42 days before first study dose) and endoscopy
• Previous chemotherapy treatment completed 28 days before first study dose
• No oesophageal stent in-situ
• Any gender, aged ≥16 years.
• Life expectancy of at least 12 weeks
• ECOG performance score of 0-1
• Able to comply with protocol fully - absence of any physical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Able to give written (signed and dated) informed consent according to GCP before registration
• Hematological and biochemical indices within the ranges below:
• Haemoglobin: ≥8.0g/dL
• Platelet count : ≥100x10^9/L
• Absolute neutrophil count: ≥1.5x10^9/L
• Total bilirubin: ≤1.5 x upper limit of normal unless the subject has known or suspected Gilbert's syndrome
• AST/ALT: ≤2.5 times the upper limit of normal; ≤5 times if liver metastases
• Estimated glomerular filtration rate: ≥40ml/min

For Stage A2:

• Any histologically confirmed advanced solid tumor that is metastatic or unresectable where Investigator considers Cisplatin and Capecitabine based regimen as appropriate.
• Baseline investigations available: staging CT scan (within 35 days before first study dose)
• Previous chemotherapy treatment completed 28 days before first study dose
• Any gender, aged ≥16 years
• Life expectancy of at least 12 weeks
• ECOG performance score of 0-1
• Able to comply with protocol fully - absence of any physical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Able to give written (signed and dated) informed consent according to GCP before registration
• Hematological and biochemical indices within the ranges below:
• Haemoglobin: ≥10.0g/dL
• Platelet count : ≥100x10^9/L
• Absolute neutrophil count: ≥1.5x10^9/L
• Total bilirubin: ≤1.5 x upper limit of normal unless the subject has known or suspected Gilbert's syndrome
• AST/ALT: ≤2.5 times the upper limit of normal; ≤5 times if liver metastases
• Ca, Mg, Phosphate: within normal limits
• Estimated glomerular filtration rate: ≥60ml/min

For Stage B:

• Histologically confirmed adenocarcinoma or squamous cell carcinoma of the oesophagus including Siewert type 1 or 2 tumors with ≤2cm gastric mucosal extension (not including cervical oesophagus)
• Tumor length 7cm or less
• Suitable for radical CRT and surgery not an option due to being medically unfit or unsuitable for surgery or patient choice
• No oesophageal stent in-situ
• Endoscopically or radiologically documented measurable disease
• Diagnostic PET CT scan*
• Staging CT scan*

*either CT or PET CT scan within 42 days of first study dose

• Adequate respiratory and cardiac function tests for safe delivery of CRT in the opinion of the Principle Investigator, specifically cardiac ejection fraction ≥60% and lung function FEV1>1 litre or 40% of predicted value or KCO (DLCO/VA) >40% predicted value.
• Any gender, aged ≥16 years
• ECOG performance score of 0-1
• Able to comply with protocol fully - absence of any physical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Able to give written (signed and dated) informed consent according to GCP before regist