NCT05955157

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

Status unknown Phase 2/Phase 3 Last updated 8 January 2024

What this trial tests

Phase 2/Phase 3 trial testing Dendritic cell + Cytokine-induced killer cell (DC+CIK) immunotherapy in Pancreatic Ductal Adenocarcinoma in 52 participants. Status unknown.

Timeline

3 January 2023

Primary endpoint
1 December 2024

1 June 2025

Quick facts

Lead sponsor	University of Malaya
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	3 January 2023
Primary completion	1 December 2024
Estimated completion	1 June 2025
Sites	1 location across Malaysia

Drugs / interventions tested

• Dendritic cell + Cytokine-induced killer cell (DC+CIK) immunotherapy — full drug profile →
• Tegafur Only Product — full drug profile →

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

University of Malaya

Who can join

Adults 18 to 80, any sex, with Pancreatic Ductal Adenocarcinoma or Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of participants with treatment-related adverse events
  Time frame: 3 months
  Safety of patients towards treatment will be evaluated based on number of adverse events (AEs) and serious adverse events (SAEs) reported.
• Incidence of treatment-emergent hematologic side effects
  Time frame: 3 months
  Feasibility of experimental treatment will be evaluated based on result of differential complete blood count.

Sponsor's own description

The goal of this randomized phase 2 controlled clinical trial is to study safety, efficacy of S-1 combined DC+CIK maintenance therapy compared with S-1 alone in improving clinical benefit rate (CBR) among advanced PDAC patients. The main objectives aim to be achieved through this study are :

1. To evaluate the safety of DC+CIK combined immunotherapy when administered with the chemotherapy S-1 as maintenance therapy following first-line chemotherapy regime to advanced pancreatic ductal adenocarcinoma patients.
2. To demonstrate the superiority of of DC+CIK combined immunotherapy in improving clinical benefit rate (CBR) of advanced pancreatic ductal adenocarcinoma patients when administered with the chemotherapy S-1 as maintenance therapy following first-line chemotherapy regime.
3. To investigate the ability of S-1 combined DC+CIK maintenance therapy in reducing pancreatic ductal adenocarcinoma patients' circulating cancer stem cells (CSCs).

In this study, subjects 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, they 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. Additional third cycle can be performed on those who tolerate well with no toxicity or respond very well. Patients from treatment group will be assessed for their eligibility to receive booster dose on following conditions: 1) tumour achieves partial response or stable disease and 2) ECOG-PS performance status of 0-2 and 3) doesn't exhibit grade 1 and 2 toxicities to improve tumour control.

Additionally, S-1 will be given twice daily after meals for 2 weeks as first cycle along with DC+CIK. Next second cycle of S-1 will be given after 7-days (1 week) rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent. Dose of S-1 will be determined according to the body surface area.

Meanwhile, patients from control group will receive S-1 alone as maintenance therapy twice daily after meals for 14 days (2 weeks) as one cycle. The next cycle of S-1 will be given after 7-days rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: anticancer vaccination with dendritic cells.
   Borges F, Laureano RS, Vanmeerbeek I, Sprooten J, et al · · 2024 · cited 18× · PMID 39398476 · DOI 10.1080/2162402x.2024.2412876
2. Unveiling the resistance to therapies in pancreatic ductal adenocarcinoma.
   Shah A, Ganguly K, Rauth S, Sheree SS, et al · · 2024 · cited 14× · PMID 39243602 · DOI 10.1016/j.drup.2024.101146
3. Pancreatic Cancer: Pathogenesis and Clinical Studies.
   Zhou K, Liu Y, Tang C, Zhu H. · · 2025 · cited 6× · PMID 40182139 · DOI 10.1002/mco2.70162
4. Advancing Immunotherapy in Pancreatic Cancer: A Brief Review of Emerging Adoptive Cell Therapies.
   Sherpally D, Manne A. · · 2025 · cited 3× · PMID 40002184 · DOI 10.3390/cancers17040589
5. Application of dendritic cell extracellular vesicles as a valid nanoparticle platform for cancer therapies: a narrative review.
   Nezamdoust FV, Nezhad-Mokhtari P, Mirzaahmadi B, Mazloumi Z, et al · · 2026 · PMID 42010708 · DOI 10.1186/s13287-026-05011-7
6. Targeting IL-12 for pancreatic cancer immunotherapy: advances in delivery strategies and clinical translation.
   Schlatter J, Wei W, Chen Y, Melse A, et al · · 2026 · PMID 41958651 · DOI 10.3389/fimmu.2026.1755796
7. Immune Exhaustion in Chronic Infection and Cancer: Signaling Pathways and Therapeutic Interventions.
   Song Y, Mo Y, Chen S, Chen Y, et al · · 2026 · PMID 41768369 · DOI 10.1002/mco2.70635