Stereotactic Body Radiation Therapy and vNKT Cell Adoptive Therapy for Advanced Pancreatic Cancer: a Phase 2 Trial

Trial ID: NCT05783076

Interventional - Phase 2 - Unknown status

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

• Pancreatic Cancer

Interventions

• Stereotactic body radiation therapy
• adoptive cell therapy with vNKT cells

Eligibility

Inclusion criteria

• 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

• 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.

Sponsor

Changhai Hospital

Source: Clinicaltrials.gov

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