Clinical trial · Interventional
SBRT Plus vNKT for Pancreatic Cancer
Stereotactic Body Radiation Therapy and vNKT Cell Adoptive Therapy for Advanced Pancreatic Cancer: a Phase 2 Trial
NCT05783076CI-TRIAL-00069178unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Owing to that the previous study of the investigators showed that SBRT plus pembrolizumab and trametinib provided favorable outcomes compared with SBRT plus gemcitabine for pancreatic cancer, therefore, the investigators aim to further investigate the efficacy and safety of SBRT plus another kind of immunotherapy, namely adoptive cell therapy (vNKT cell), for advanced pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adoptive cell therapy with vNKT cells | Drug | — | UNRESOLVED |
| Stereotactic body radiation therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- stereotactic body radiation therapy plus vNKT cells
- description
- Stereotactic body radiatuon therapy is performed by Cyberknife, an image-guided frameless stereotactic robotic radiosurgery system (Accuray Corporation, Sunnyvale CA). Prescription doses ranged from 35-40Gy/5f. Allogeneic peripherial blood monocytes (PBMC) are collected from healthy individuals. vNKT cells are isolated from PBMC and then expanded. Quality tests shoud be performed before isolated cells become cell therapy products. After quality control, vNKT cells should be transfused into patients within 24 hours. Adoptive cell therapy is initiated 2-3 weeks after SBRT. Cell therapy is performed twice a month with the interval of 24-48 hours within 6 months after SBRT. The number of vNKT cells transfused once is 1.5×10\^8/Kg±15%. While cell therapy is performed once a months 6 months after SBRT. Cell therapy will be delivered for one year or until disease progression if it occurs within one year.
- interventionNames
- Drug: Stereotactic body radiation therapy
- Drug: adoptive cell therapy with vNKT cells
Primary outcomes (1)
- measure
- Overall survival will be determined
- timeFrame
- From randomization to death irrespective of cause, assessed up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age more than 18 years. 2. Pathological confirmed pancreatic ductal adenocarcinoma. 3. No previous immunotherapy or radiotherapy, or more than one year after the last course of radiotherapy. 4. History of sugery or chemotherapy, and documented disease progressions after these therapies. 5. ECOG performance status of 0-2 points. 6. Normal results of laboratory tests, including WBC ≥4.0×10\^9/L, Neu ≥2.0×10\^9/L, Hb ≥120g/L, Plt ≥100×10\^9/L; AST, ALT \<2.5 times of the upper limit of normal, total bilirubin \<17.1μmol/L, creatinine \<110μmoI/L; international normalized ratio in coagulation test \<2.0 7. Willing to participate in the study and complete follow-up examinations as required. Exclusion Criteria: 1. History of immunotherapy, or less than one year after the last course of radiotherapy. 2. History of other tumors. 3. Confirmed synchronous multiple tumors. 4. ECOG performance status of more than 2 points. 5. Active inflammatory bowel disease, or peptic ulcer. 6. History of gastrointestinal bleeding or perforation within 6 months. 7. Infections required antibiotics. 8. Positive HBsAg or HCV antibody. 9. Positive HIV antibody. 10. Impaired heart function (NYHA III-IV level), respiratory insufficiency. 11. Confirmed genetic diseases. 12. History of hematologic diseases, including leukemia, lymphoma, myeloma or myelodysplastic syndrome. 13. History of stem cell or organ transplantation. 14. History of autoimmune diseases except leukoderma punctata. 15. Severe anaphylaxis. 16. Long term use of immunosuppressors or steroids. 17. Receiving chemotherapy at the time of screening stage, or participation of other studies. 18. Pregnancy or lactation. 19. Unable to understand the whole procedure of study and provide written informed consent. 20. No comprehensive understanding about patients' immune functions.
References
Publications (1)
- DERIVEDZhu X, Yin X, Liu W, Yu C, Xia S, Cao Y, Jiang L, Guo Z, Zhang M, Zhang H. Stereotactic body radiation therapy plus adoptive vNKT cell therapy for pancreatic cancer: protocol of a phase II trial. Immunotherapy. 2025 Jul;17(10):685-692. doi: 10.1080/1750743X.2025.2533112. Epub 2025 Jul 16. PMID 40671381