Combining radiation therapy with a new type of immune cell treatment for pancreatic cancer

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

This study is testing if combining a new immune cell treatment with radiation therapy can help people with advanced pancreatic cancer who can't have surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changhai Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy, pembrolizumab, trametinib, CAR-T, chimeric antigen receptor, radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT05783076 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of combining stereotactic body radiation therapy (SBRT) with vNKT cell therapy for patients with advanced pancreatic cancer. The study builds on previous findings that SBRT combined with other treatments has shown favorable outcomes. Participants will receive SBRT alongside adoptive cell therapy using vNKT cells, which are a novel approach in treating solid tumors. The trial aims to improve treatment options for patients who are not candidates for surgery and have limited responses to existing therapies.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with confirmed pancreatic ductal adenocarcinoma who have not received prior immunotherapy or radiotherapy.

Not a fit: Patients with a history of other tumors or those with an ECOG performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced pancreatic cancer.

How similar studies have performed: While there have been promising results with other immunotherapy approaches, the combination of SBRT with vNKT cell therapy is a novel approach that has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Changhai Hospital affiliated to Naval Medical University — Shanghai, China (RECRUITING)

Conditions: Pancreatic Cancer