Combining S-1 with immune therapy for advanced pancreatic cancer
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
PHASE2; PHASE3 · University of Malaya · NCT05955157
This study is testing if combining a chemotherapy drug called S-1 with a type of immune therapy can help people with advanced pancreatic cancer stay healthier after their initial treatment.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Malaya (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Petaling Jaya, Kuala Lumpur) |
| Trial ID | NCT05955157 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of combining S-1 chemotherapy with dendritic cell and cytokine-induced killer cell (DC+CIK) immunotherapy as maintenance therapy for patients with advanced pancreatic ductal adenocarcinoma (PDAC). It is a randomized phase 2 controlled trial that will compare the clinical benefit rate of this combination therapy against S-1 alone in patients who have achieved stable disease after first-line chemotherapy. The study will also investigate the impact of this combined therapy on circulating cancer stem cells in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed advanced pancreatic ductal adenocarcinoma who have undergone first-line chemotherapy and achieved stable disease.
Not a fit: Patients who are pregnant, have active infections, or are currently enrolled in another clinical study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with advanced pancreatic cancer.
How similar studies have performed: While the combination of chemotherapy and immunotherapy is a growing area of interest, this specific approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 5. Life expectancy more than three months. Exclusion Criteria: 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 5. Patients who undergo radiotherapy to pancreas or metastatic site need to be recovered from the toxicities
Where this trial is running
Petaling Jaya, Kuala Lumpur
- Clinical Oncology Department, Ummc — Petaling Jaya, Kuala Lumpur, Malaysia (RECRUITING)
Study contacts
- Study coordinator: HO GWO FUANG, MBBS
- Email: gwoho@um.edu.my
- Phone: 03-79492120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor, Cell-based Immunotherapy, S-1 combined DC+CIK maintenance treatment, DC+CIK immunotherapy