Table 2 Activity schedule for phase II clinical trial in gastrointestinal tumors

Time point

Week 1

Week 2

Week 6

Week 10

Week 12 -14

Enrolment

 Screening and Informed Consent

X

 Physical Examen

X

X

X

X

 Clinical Record

X

X

X

X

 HIV Test and Pregnancy test

X

Interventions

 Medication dispensing

X

X

X

X

 Follow-up visit

X

X

X

X

Safety Assessment

 Hemogram

X

X

 Transaminase AST

X

X

 Transaminase ALT

X

X

 Alkaline Phosphatase

X

X

 Total Bilirubin

X

X

 Triglycerides

X

X

 Total Cholesterol

X

X

 Blood Urea Nitrogen (BUN)

X

X

 Creatinine

X

X

 Urinalysis

X

X

 Uric Acid

X

X

 LDH (Lactate Dehydrogenase)

X

X

 Lactic Acid

X

X

 Ferritin

X

X

 Albumin

X

X

 Iron

X

X

 Electrocardiogram

X

X

 Echocardiogram

X

X

Efficacy Assessment

 RECIST

X

X

 Tumor Antigens

X

X

 CA199

X

X

 ACE

X

X

 Metabolome

X

X

X

 Microbiome Analysis

X

X

 Proinflammatory Cytokines

X

X

X

 Circulating DNA

X

X

X

 Ketone Bodies

X

X

X

 Tumor Infiltration

X

X

 QLQ C-30 Quality of Life Surveys

X

X

X

X

 Progression-Free Survival

X

X