SBRT Plus vNKT for Pancreatic Cancer

NCT05783076 | Unknown Phase 2 DMC

• 1 other identifier: ChangHai PDAC
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Overall survival will be determined

  From randomization to death irrespective of cause

  From randomization to death irrespective of cause, assessed up to 2 years

Secondary Outcomes (3)

• Progression free survival will be determined

  From randomization to documentation of any clinical or radiological disease progression or death, whichever occurred first, assessed up to 2 years

• Adverse effects will be determined

  Up to 2 years

• Quality of life will be determined

  Up to 2 years

Study Arms (1)

stereotactic body radiation therapy plus vNKT cells

EXPERIMENTAL

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.

Drug: Stereotactic body radiation therapy; Drug: adoptive cell therapy with vNKT cells

Interventions

Stereotactic body radiation therapy DRUG

Details have been shown in arm descriptions.

Also known as: Radiotherapy

stereotactic body radiation therapy plus vNKT cells

adoptive cell therapy with vNKT cells DRUG

Details have been shown in arm descriptions.

Also known as: adoptive cell therapy

stereotactic body radiation therapy plus vNKT cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years.
• Pathological confirmed pancreatic ductal adenocarcinoma.
• No previous immunotherapy or radiotherapy, or more than one year after the last course of radiotherapy.
• History of sugery or chemotherapy, and documented disease progressions after these therapies.
• ECOG performance status of 0-2 points.
• 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
• Willing to participate in the study and complete follow-up examinations as required.

You may not qualify if:

• History of immunotherapy, or less than one year after the last course of radiotherapy.
• History of other tumors.
• Confirmed synchronous multiple tumors.
• ECOG performance status of more than 2 points.
• Active inflammatory bowel disease, or peptic ulcer.
• History of gastrointestinal bleeding or perforation within 6 months.
• Infections required antibiotics.
• Positive HBsAg or HCV antibody.
• Positive HIV antibody.
• Impaired heart function (NYHA III-IV level), respiratory insufficiency.
• Confirmed genetic diseases.
• History of hematologic diseases, including leukemia, lymphoma, myeloma or myelodysplastic syndrome.
• History of stem cell or organ transplantation.
• History of autoimmune diseases except leukoderma punctata.
• Severe anaphylaxis.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital affiliated to Naval Medical University

Shanghai, 200433, China

RECRUITING

Related Publications (1)

• Zhu 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; Radiotherapy; Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 24, 2023
• Study Start: June 25, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

CN (1)