Table 1 Schedule of activities for the CS003-BC phase II clinical study

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

X

X

 Transaminase AST

X

X

X

X

 Transaminase ALT

X

X

X

X

 Alkaline Phosphatase

X

X

X

X

 Total Bilirubin

X

X

X

X

 Triglycerides

X

X

X

X

 Electrocardiogram^a

X

X

X

 Echocardiogram^a

X

X

X

Efficacy Assessment

 RECIST^a

X

X

X

 Metabolome^a

X

X

X

 Microbiome Analysis^a

X

X

X

 Tumor Infiltrate^a

X

X

X

 Progression-Free Survival

X

 QLQ C-30 Quality of Life Surveys

X

X

X

 QLQ BR-23 Quality of Life Surveys

X

X

X