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Trial Title:
SBRT Plus vNKT for Pancreatic Cancer
NCT ID:
NCT05783076
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Stereotactic body radiation therapy
Description:
Details have been shown in arm descriptions.
Arm group label:
stereotactic body radiation therapy plus vNKT cells
Other name:
Radiotherapy
Intervention type:
Drug
Intervention name:
adoptive cell therapy with vNKT cells
Description:
Details have been shown in arm descriptions.
Arm group label:
stereotactic body radiation therapy plus vNKT cells
Other name:
adoptive cell therapy
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.
Detailed description:
Pancreatic cancer still remains one of the most lethal malignancies and fourth leading
cancer cause of death in US, with a slight increasing incidence and the lowest 5-year
survival rate of 9%. Although surgical resection is considered as the radical treatment,
most patients were not amenable to surgery due to the initial diagnosis of advanced
pancreatic cancer. For those patients, stereotactic body radiation therapy (SBRT),
recommended as the local treatment, combining with chemotherapy is the optimal treatment.
Despite improved knowledge about the genetic background and an increasing understanding
of the tumor microenvironment, immunotherapy especially immune checkpoint inhibitors,
although efficient for many solid malignancies, including metastatic melanoma and lung
cancer, have not yielded any clinical benefit in pancreatic cancer.
In addition to immune checkpoint inhibitors, chimeric antigen receptor T cell (CAR-T) has
shown promising efficacy in hematologic malignancies. Nowadays, adoptive cell therapy
includes CD8+ T cells and NK cells modified with chimeric antigen receptors. However, due
to limited technology, expansion of specific CD8+ T cells is quite difficult.
Additionally, there is lack of specific tumor antigens in solid tumors, which results in
unsatisfactory outcomes of CAR-T and CAR-NK cells targeting solid tumors. Therefore,
novel cell therapies may provide insights into therapies for solid tumors. Recently, vNKT
and γδT cells used in trials of cell therapy have aroused attention.
NKT cells possess both phenotypes of T cells and NK cells. Hence, NKT cells could secret
various cytokines and chemokines after stimulations to enhance anti-tumor immunity
independent of MHC. Also, cytotoxic effects of NKT cells could be activated via T cell
receptors (TCR) targeting specific antigens. There are two kinds of NKT cells. One is
classic NKT cells with invariant TCR which are specialized CD1d-restricted T cells that
recognize lipid antigens, called iNKT (invariant NKT) cells. The other is
non-CD1d-restrcited. This CD8+ NKT cells has more potent anti-tumor effects than
conventional T and NK cells, which is manifested by killing tumor cells and myeloid
derived suppressor cells. Owing to recognition of MHC-restricted antigens via diverse
TCRs, they are called vNKT (variant NKT) cells.
Furthermore, our previous studies has clarified favorable outcomes from the synergy of
SBRT plus immunotherapy for pancreatic cancer. Therefore, the investigators aim to
investigate the efficacy and safety of SBRT plus vNKT cell adoptive therapy for advanced
pancreatic cancer.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai Hospital affiliated to Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Huojun Zhang
Phone:
86-021-31162207
Email:
chyyzhj@163.com
Contact backup:
Last name:
Xiaofei Zhu
Phone:
86-021-31162211
Email:
zhuxiaofei_zxf@163.com
Start date:
June 25, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05783076
