Phase II Randomized Controlled Trial Of Dendritic Cell + Cytokine-Induced Killer Cell Immunotherapy With S-1 Versus S-1 Alone As Maintenance Therapy For Advanced Pancreatic Ductal Adenocarcinoma Patients

This trial is designed as randomized phase 2 controlled clinical trial.

Subjects who fulfill following inclusion criteria will be admitted to this phase 2 trial and will be excluded if they fulfill any one of the exclusion criteria. All patients must have undergone first-line of chemotherapy (either modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease. The inclusion criteria are as follow: 1) histologically and cytologically confirmed advanced pancreatic ductal adenocarcinoma according to AJCC (American Joint Committee on Cancer) TNM system; 2) have undergone first-line of chemotherapy (modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease; 3) Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2; 4) age above 18 ages and 5) life expectancy more than three months. Meanwhile, the exclusion criteria are 1) pregnant and lactating women; 2) concomitant beta-adrenergic drug blockers medication; 3) active infection; 4) current enrollment in another clinical study with an investigational agent and 5) patients who undergo pancreas or metastatic site radiotherapy need to be recovered from the toxicities.

Next, patients who achieve at least stable disease will be checked for peripheral blood mononuclear cells (PBMC) adequacy, hematoprofiling using full blood count (FBC) and their baseline status. This is followed by leukapheresis once all conditions satisfied and met. Apheretic products will be sent to local sponsor-contracted laboratory prior for incubation of patients' immune cells with PDAC antigens under specific medium.

All subjects in this trial have been diagnosed with advanced stage of PDAC and being treated with standard chemo: modified FOLFIRINOX or gemcitabine-based regime for at least 3 months. Once the DC+CIK infusion bags are ready to be manufactured, those who achieve at least stable disease or partial response will be randomized in ratio of 1:1 into treatment group: DC-CIK plus S1 (27 patients) and control group: S-1 alone (27 patients).

For treatment group, DC+CIK infusion bag will be administrated right after 17 days patients discharged. Patients will be infused with DC first, followed by CIK immune cells on day 1. DC+CIK immunotherapy will be repeated for another 2 times (day 8 and 15) as one cycle. All patients are left to rest for a week (start from day 21) prior to receive another 3 times of infusion (day 28, 35 and 42) if condition allowed. DC+CIK immunotherapy will be offered as two cycles for every patient in treatment group.