Pancreatic CancerPhase 2NCT05783076
SBRT Plus vNKT for Pancreatic Cancer
A Phase 2 study testing Stereotactic body radiation therapy and adoptive cell therapy with vNKT cells in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Stereotactic body radiation therapy and adoptive cell therapy with vNKT cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2023to 1 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Long term use of immunosuppressors or steroids.
- Receiving chemotherapy at the time of screening stage, or participation of other studies.
- Pregnancy or lactation.
- Unable to understand the whole procedure of study and provide written informed consent.
- No comprehensive understanding about patients' immune functions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital affiliated to Naval Medical University
Shanghai, 200433
Huojun Zhang, 86-021-31162207, chyyzhj@163.com
Xiaofei Zhu, 86-021-31162211, zhuxiaofei_zxf@163.com
About this study
Official title: Stereotactic Body Radiation Therapy and vNKT Cell Adoptive Therapy for Advanced Pancreatic Cancer: a Phase 2 Trial
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Stereotactic body radiation therapy, adoptive cell therapy with vNKT cells
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapyDrug
Also called Radiotherapy
Details have been shown in arm descriptions.
adoptive cell therapy with vNKT cellsDrug
Also called adoptive cell therapy
Details have been shown in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Stereotactic body radiation therapy; Drug: adoptive cell therapy with vNKT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival will be determined
From randomization to death irrespective of cause
Measured: 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
Measured: 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
Assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE; version 4.0)
Measured: Up to 2 years
Quality of life will be determined
Assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. The score of each scale ranges from 0 to 100. Higher scores in function domains and global health status indicate better quality of life, while higher scores in symptom domains imply worse quality of life.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start25 Jun 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783076
- Sponsor's protocol ID
- ChangHai PDAC
- Status last verified
- Aug 2023
- First submitted
- 2 Mar 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40671381
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy and vNKT Cell Adoptive Therapy for Advanced Pancreatic Cancer: a Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05783076
- Acronym / sponsor ID
- ChangHai PDAC
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stereotactic body radiation therapy plus vNKT cells | Experimental | Drug: Stereotactic body radiation therapy, Drug: adoptive cell therapy with vNKT cellsStereotactic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiation therapyAlso: RadiotherapyDetails have been shown in arm descriptions. | Drug | stereotactic body radiation therapy plus vNKT cells |
| adoptive cell therapy with vNKT cellsAlso: adoptive cell therapyDetails have been shown in arm descriptions. | Drug | stereotactic body radiation therapy plus vNKT cells |
Primary outcome
Overall survival will be determined
Time frame: From randomization to death irrespective of cause, assessed up to 2 years
From randomization to death irrespective of cause
3 secondary outcomes
Progression free survival will be determined
Time frame: 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
Time frame: Up to 2 years
Quality of life will be determined
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 40671381Zhu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changhai Hospital affiliated to Naval Medical University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiation therapy and adoptive cell therapy with vNKT cells in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival will be determined (time frame: From randomization to death irrespective of cause, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05783076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.