NCT05955157 — drugset

Summary

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.

Timeline

Start: 2023-01-03
Primary completion: 2024-12
Completion: 2025-06

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CIK cells	Cell therapy	—	—
Subject	Dendritic Cell	Cell therapy	—	—
Subject	S-1	Small molecule	—	—

Combined S-1 With DC+CIK As Maintenance Therapy For Advanced Pancreatic Ductal Adenocarcinoma

Summary

Timeline

Publications

Drugs

Indications