Primary Objective: * Response rate (by contrast CT scan) Secondary Objectives: * Progression-free survival (PFS) * Overall survival (OS)
The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
Response rate (by contrast CT scan)
Time frame: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
Progression Free survival (PFS)
Time frame: Day 1 of treatment to the date of objective disease progression
Overall survival (OS)
Time frame: Day 1 of treatment to the date of death due to any cause
Adverse events (including oesophageal and pulmonary toxicities)
Time frame: Informed consent signature up to 12 weeks after completion of treatment
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