Pancreatic CancerCARTNCT06054308
Mesothelin-targeted CAR-T Cells as a Neo-adjuvant Treatment in Patients With Resectable Pancreatic Cancers: a Feasibility Study
A study testing MSLN CART in people with Pancreatic Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) is a cancer of grave prognosis, with only about 10% of patients alive at 5 years after diagnosis. Primary surgical resection is feasible in about 10-15% of patients with an early-stage disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- MSLN CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Feb 2024to 2 Aug 2026
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed pancreatic cancer planned for curative resection.
- Age 18 to 70 years old
- Measurable tumors according to RECIST 1.1s
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- A sufficient number of T cells taken through lymphopheresis (CD3+ T cells>1x109).
- Patients with preserved organ function as evidenced by
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- Haematological: Hemoglobin ≥ 8g/dL; Platelet ≥ 75×109/L; INR≤1.5; Absolute neutrophil count (ANC) ≥ 1.5
- ×109 /L; Absolute lymphocyte count ≥ 0.4×109 /L
- Renal: Creatinine < 1.5 upper limit normal (ULN) mg/dL or Creatinine clearance ≥40 ml/min
- Bilirubin <1.5 ULN μmol/L; Alanine Aminotransferase (ALT) <3 IU/L; Albumin ≥30 g/L
- Willing and able to provide written, signed informed consent
- Sexually active subjects must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 12 months after the last dose
- Females of childbearing potential must have a negative serum pregnancy test at screening and willing to have additional pregnancy tests during the study.
- Females considered non-childbearing potential include those who have been in menopause for at least 1 year or had tubal ligation at least 1 year prior to screening, or who have had total hysterectomy
Who cannot join
- Patients with AIDS
- Patients with serum HBsAg positive
- The patient has an active or uncontrolled infection.
- Subjects with severe heart, brain, liver, kidney or hematopoietic diseases, or psychosis who are not suitable for surgical resection
- In the first evaluation experiment, expansion ability of T cells activated by Cluster of Differentiation (CD) CD3/CD28 magnetic beads is less than 5 times.
- Pregnant or lactating women
Show all 12Show fewer
- Those who participate in other clinical trials.
- History of chronic pancreatitis or Immunoglobulin G4 (IgG4) disease
- Patients who require splenectomy during surgery for pancreatic cancer. History of second malignancy except for any of the following:
- ( • Carcinoma in situ of the cervix or non-melanoma skin cancer ) ( • A cancer diagnosed and curatively treated ≥5 years prior to leukapheresis with no subsequent evidence of cancer recurrence )
- History of or waiting for organ transplantation, including liver transplantation
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Trial locations and contacts
1 site in 1 country.
About this study
Pancreatic ductal adenocarcinoma (PDAC) is a cancer of grave prognosis, with only about 10% of patients alive at 5 years after diagnosis. Primary surgical resection is feasible in about 10-15% of patients with an early-stage disease. Another 30-35% of patients have locally advanced disease with invasion into major vasculature but without detectable metastases. Surgery offers a chance of cure. The introduction of adjuvant multi-agent chemotherapy has improved prognosis after surgery.
In the management of patients with PDAC, the role of neoadjuvant therapy is less certain. Neoadjuvant therapy for pancreatic cancer can in theory control early systemic spread and improve rate of having no macroscopic or microscopic residual tumor (R0 resection). In the The European Study Group for Pancreatic Cancer (ESPAC-5) study, neoadjuvant combination chemotherapy did not increase rate of resection who had borderline-resectable disease but appears to improve overall survival (OS).
Read more
Chimeric antigen receptor (CAR) T-cell therapy may represent a new paradigm in the treatment of pancreatic cancer. Mesothelin (MSLN) is a 40 kDa membrane protein not expressed in normal cells, but highly expressed in a variety of cancer cells, such as mesothelioma, lung, breast, ovarian, gastric and pancreatic cancer. MSLN is expressed about 80% of PDAC.
There are several immunotherapies targeting MSLN for PDAC treatment, including antibody-based drugs (monoclonal antibodies, antibody-drug conjugates, immunotoxins), vaccines, and CAR-T cell therapy.
The safety of CAR-T cells targeting MSLN in the treatment of cancers has also been verified in several clinical trials on lung cancers (NCT01583686, NCT02414269, NCT01355965). Professor Li Peng's group at the Chinese Academy of Science designed third generation CAR-T cells targeting MSLN and validated their use in both human PDAC cell lines, animal models, and in 4 patients with advanced malignancies. In a 42-year-old man with metastatic PDAC, the MSLN targeted CAR-T treatment led to complete response follow several hepatic artery infusion and intravenous infusion. These early cases confirmed the safety of these MSLN targeted CAR-T cells.
In the current proposed feasibility study, the researcher hypothesise that Endoscopic ultrasound (EUS)-guided injection of MSLN targeted CAR-T cells into PDAC can induce a tumor response, improve rate of R0 resection and translate into better patient survival.
Read the detailed description
In the management of patients with PDAC, the role of neoadjuvant therapy is less certain. Neoadjuvant therapy for pancreatic cancer can in theory control early systemic spread and improve rate of R0 resection (2). In the ESPAC-5 study, neoadjuvant combination chemotherapy did not increase rate of resection who had borderline-resectable disease but appears to improve overall survival (OS) (3). The Charité Onkologie (CONKO-007) trial showed that the addition of radiation to chemotherapy improved R0 resection rate and complete pathological response (pCR) but did not impact on OS (4).
Chimeric antigen receptor (CAR) T-cell therapy may represent a new paradigm in the treatment of pancreatic cancer. Mesothelin (MSLN) is a 40 kDa membrane protein minimally expressed in normal cells, but highly expressed in a variety of cancer cells, such as mesothelioma, lung, breast, ovarian, gastric and pancreatic cancer. MSLN is expressed in about 80% of PDAC.
Mesothelin is the receptor of tumor antigen CA-125 (also known as MUC16). Tumor expressing CA-125 can combine with mesothelin on the surface of mesothelial cells in pleural or peritoneal cavity, resulting in increased cell adhesion and promoting metastatic diffusion (5). In pancreatic cancers, mesothelin plays a role in tumorigenesis by increasing cell proliferation, migration and S phase cell population. Its limited expression in normal human tissues and high expression in many cancers make it an attractive tumor-related antigen for cancer treatment (6).
There are several immunotherapies targeting MSLN for PDAC treatment, including antibody-based drugs (monoclonal antibodies, antibody-drug conjugates, immunotoxins), vaccines, and CART cell therapy. For example, the recombinant protein preparation SS1(dsFv)PE38 (SS1P), which is composed of high affinity Fv (variable fragment) targeting MSLN and Pseudomonas exotoxin A (PE) fusion, has entered clinical trials as a drug (7). There is also an antibody-drug conjugate, Anetumab ravtansine (BAY 94-9343), which is made by conjugating human anti-MSLN antibody with maytansinol tubulin inhibitor (DM4) through a connector containing disulfide bond. In vivo, anetumab ravtansine is specifically localized in tumors that express MSLN and inhibits the growth of pancreatic cancer, ovarian cancer, mesothelioma and other tumors. The safety of CAR-T cells targeting MSLN in the treatment of cancers has also been verified in several clinical trials on lung cancers (NCT01583686, NCT02414269, NCT01355965). Professor Li Peng's group at the Chinese Academy of Science designed third generation CAR-T cells targeting MSLN and validated their use in both human PDAC cell lines, animal models, and in 4 patients with advanced malignancies. In a 42-year-old man with metastatic PDAC, the MSLN targeted CAR-T treatment led to complete response following several hepatic artery infusion and intravenous infusion. These early cases confirmed the safety of these MSLN targeted CAR-T cells.
In the current proposed feasibility study, the researcher hypothesize that EUS-guided injection of MSLN targeted CAR-T cells into PDAC can induce a tumor response, improve rate of R0 resection and translate into better patient survival.
- Conditions
- Pancreatic Cancer
- Being tested
- MSLN CART
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSLN CARTOther
Endoscopic ultrasound guided injection of mesothelin-targeted CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| MSLN CART | Experimental | Endoscopic ultrasound guided injection of mesothelin-targeted CAR-T cells Receives: Other: MSLN CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic response
Proportion of major pathologic response on resected specimen of pancreatic tumour
Measured: 3 months
Secondary outcomes (4)
Radiological response
Radiological response according to RECIST 1.1 measured on CT 4 weeks after EUS guided MSLN CAR-T injection (i.e. tumor volumetric reduction at trial entry and 4 weeks after MSLN CAR-T injection).
Measured: 4 weeks
Rate of R0 surgical resection
Rate of R0 surgical resection after EUS-guided injection of MSLN-targeted CAR-T cells
Measured: 3 months
Serious Adverse Event
Incidence rate of serious adverse events of grade III and above.
Measured: 1 year
Disease free and overall survival
Disease free and overall survival
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start2 Feb 2024 (estimated)
- Primary completion2 Feb 2026 (estimated)
- Study completion2 Aug 2026 (estimated)
Why it stopped: Unable to obtain Clinical Trial Certificate due to tech Unable to obtain Clinical Trial Certificate due to technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 Chinese University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, MD, Chinese University of Hong Kong
- Investigators
- James Lau, MD, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054308
- Sponsor's protocol ID
- The Chinese University of Hong
- Acronym
- CART
- Status last verified
- Aug 2024
- First submitted
- 19 Sep 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851-862. doi: 10.1001/jama.2021.13027.
PubMed 34547082Springfeld C, Ferrone CR, Katz MHG, Philip PA, Hong TS, Hackert T, Buchler MW, Neoptolemos J. Neoadjuvant therapy for pancreatic cancer. Nat Rev Clin Oncol. 2023 May;20(5):318-337. doi: 10.1038/s41571-023-00746-1. Epub 2023 Mar 17.
PubMed 36932224Ghaneh P, Palmer D, Cicconi S, Jackson R, Halloran CM, Rawcliffe C, Sripadam R, Mukherjee S, Soonawalla Z, Wadsley J, Al-Mukhtar A, Dickson E, Graham J, Jiao L, Wasan HS, Tait IS, Prachalias A, Ross P, Valle JW, O'Reilly DA, Al-Sarireh B, Gwynne S, Ahmed I, Connolly K, Yim KL, Cunningham D, Armstrong T, Archer C, Roberts K, Ma YT, Springfeld C, Tjaden C, Hackert T, Buchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. Immediate surgery compared with short-course neoadjuvant gemcitabine plus capecitabine, FOLFIRINOX, or chemoradiotherapy in patients with borderline resectable pancreatic cancer (ESPAC5): a four-arm, multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):157-168. doi: 10.1016/S2468-1253(22)00348-X. Epub 2022 Dec 12.
PubMed 36521500Fietkau R, Ghadimi M, Grützmann R, Wittel UA, Jacobasch L, Uhl W, Croner RS, Bechstein WO, Neumann UP, Waldschmidt D, Boeck SH, Moosmann N, Reinacher-Schick AC, Golcher H, Adler W, Semrau S, Kallies A, Hecht M, Tannapfel A, Oettle H. Randomized phase III trial of induction chemotherapy followed by chemoradiotherapy or chemotherapy alone for nonresectable locally advanced pancreatic cancer: First results of the CONKO-007 trial. J Clin Oncol. 2022;40: issue 16 suppl.4008
Chen SH, Hung WC, Wang P, Paul C, Konstantopoulos K. Mesothelin binding to CA125/MUC16 promotes pancreatic cancer cell motility and invasion via MMP-7 activation. Sci Rep. 2013;3:1870. doi: 10.1038/srep01870.
PubMed 23694968Kachala SS, Bograd AJ, Villena-Vargas J, Suzuki K, Servais EL, Kadota K, Chou J, Sima CS, Vertes E, Rusch VW, Travis WD, Sadelain M, Adusumilli PS. Mesothelin overexpression is a marker of tumor aggressiveness and is associated with reduced recurrence-free and overall survival in early-stage lung adenocarcinoma. Clin Cancer Res. 2014 Feb 15;20(4):1020-8. doi: 10.1158/1078-0432.CCR-13-1862. Epub 2013 Dec 13.
PubMed 24334761Hassan R, Bullock S, Premkumar A, Kreitman RJ, Kindler H, Willingham MC, Pastan I. Phase I study of SS1P, a recombinant anti-mesothelin immunotoxin given as a bolus I.V. infusion to patients with mesothelin-expressing mesothelioma, ovarian, and pancreatic cancers. Clin Cancer Res. 2007 Sep 1;13(17):5144-9. doi: 10.1158/1078-0432.CCR-07-0869.
PubMed 17785569Wang H, Chetty R, Hosseini M, Allende DS, Esposito I, Matsuda Y, Deshpande V, Shi J, Dhall D, Jang KT, Kim GE, Luchini C, Graham RP, Reid MD, Basturk O, Hruban RH, Krasinskas A, Klimstra DS, Adsay V; Pancreatobiliary Pathology Society. Pathologic Examination of Pancreatic Specimens Resected for Treated Pancreatic Ductal Adenocarcinoma: Recommendations From the Pancreatobiliary Pathology Society. Am J Surg Pathol. 2022 Jun 1;46(6):754-764. doi: 10.1097/PAS.0000000000001853. Epub 2021 Dec 15.
PubMed 34889852
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesothelin-targeted CAR-T Cells as a Neo-adjuvant Treatment in Patients With Resectable Pancreatic Cancers: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06054308
- Acronym / sponsor ID
- CART / The Chinese University of Hong
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain Clinical Trial Certificate due to tech Unable to obtain Clinical Trial Certificate due to technical difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Feb 2024 (estimated)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 2 Aug 2026 (estimated)
- First posted
- 26 Sep 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.
Pancreatic ductal adenocarcinoma (PDAC) is a cancer of grave prognosis, with only about 10% of patients alive at 5 years after diagnosis. Primary surgical resection is feasible in about 10-15% of patients with an early-stage disease. Another 30-35% of patients have locally advanced disease with invasion into major vasculature but without detectable metastases. Surgery offers a chance of cure. The introduction of adjuvant multi-agent chemotherapy has improved prognosis after surgery.
In the management of patients with PDAC, the role of neoadjuvant therapy is less certain. Neoadjuvant therapy for pancreatic cancer can in theory control early systemic spread and improve rate of having no macroscopic or microscopic residual tumor (R0 resection). In the The European Study Group for Pancreatic Cancer (ESPAC-5) study, neoadjuvant combination chemotherapy did not increase rate of resection who had borderline-resectable disease but appears to improve overall survival (OS).
Chimeric antigen receptor (CAR) T-cell therapy may represent a new paradigm in the treatment of pancreatic cancer. Mesothelin (MSLN) is a 40 kDa membrane protein not expressed in normal cells, but highly expressed in a variety of cancer cells, such as mesothelioma, lung, breast, ovarian, gastric and pancreatic cancer. MSLN is expressed about 80% of PDAC.
There are several immunotherapies targeting MSLN for PDAC treatment, including antibody-based drugs (monoclonal antibodies, antibody-drug conjugates, immunotoxins), vaccines, and CAR-T cell therapy.
The safety of CAR-T cells targeting MSLN in the treatment of cancers has also been verified in several clinical trials on lung cancers (NCT01583686, NCT02414269, NCT01355965). Professor Li Peng's group at the Chinese Academy of Science designed third generation CAR-T cells targeting MSLN and validated their use in both human PDAC cell lines, animal models, and in 4 patients with advanced malignancies. In a 42-year-old man with metastatic PDAC, the MSLN targeted CAR-T treatment led to complete response follow several hepatic artery infusion and intravenous infusion. These early cases confirmed the safety of these MSLN targeted CAR-T cells.
In the current proposed feasibility study, the researcher hypothesise that Endoscopic ultrasound (EUS)-guided injection of MSLN targeted CAR-T cells into PDAC can induce a tumor response, improve rate of R0 resection and translate into better patient survival.
Detailed description
In the management of patients with PDAC, the role of neoadjuvant therapy is less certain. Neoadjuvant therapy for pancreatic cancer can in theory control early systemic spread and improve rate of R0 resection (2). In the ESPAC-5 study, neoadjuvant combination chemotherapy did not increase rate of resection who had borderline-resectable disease but appears to improve overall survival (OS) (3). The Charité Onkologie (CONKO-007) trial showed that the addition of radiation to chemotherapy improved R0 resection rate and complete pathological response (pCR) but did not impact on OS (4).
Chimeric antigen receptor (CAR) T-cell therapy may represent a new paradigm in the treatment of pancreatic cancer. Mesothelin (MSLN) is a 40 kDa membrane protein minimally expressed in normal cells, but highly expressed in a variety of cancer cells, such as mesothelioma, lung, breast, ovarian, gastric and pancreatic cancer. MSLN is expressed in about 80% of PDAC.
Mesothelin is the receptor of tumor antigen CA-125 (also known as MUC16). Tumor expressing CA-125 can combine with mesothelin on the surface of mesothelial cells in pleural or peritoneal cavity, resulting in increased cell adhesion and promoting metastatic diffusion (5). In pancreatic cancers, mesothelin plays a role in tumorigenesis by increasing cell proliferation, migration and S phase cell population. Its limited expression in normal human tissues and high expression in many cancers make it an attractive tumor-related antigen for cancer treatment (6).
There are several immunotherapies targeting MSLN for PDAC treatment, including antibody-based drugs (monoclonal antibodies, antibody-drug conjugates, immunotoxins), vaccines, and CART cell therapy. For example, the recombinant protein preparation SS1(dsFv)PE38 (SS1P), which is composed of high affinity Fv (variable fragment) targeting MSLN and Pseudomonas exotoxin A (PE) fusion, has entered clinical trials as a drug (7). There is also an antibody-drug conjugate, Anetumab ravtansine (BAY 94-9343), which is made by conjugating human anti-MSLN antibody with maytansinol tubulin inhibitor (DM4) through a connector containing disulfide bond. In vivo, anetumab ravtansine is specifically localized in tumors that express MSLN and inhibits the growth of pancreatic cancer, ovarian cancer, mesothelioma and other tumors. The safety of CAR-T cells targeting MSLN in the treatment of cancers has also been verified in several clinical trials on lung cancers (NCT01583686, NCT02414269, NCT01355965). Professor Li Peng's group at the Chinese Academy of Science designed third generation CAR-T cells targeting MSLN and validated their use in both human PDAC cell lines, animal models, and in 4 patients with advanced malignancies. In a 42-year-old man with metastatic PDAC, the MSLN targeted CAR-T treatment led to complete response following several hepatic artery infusion and intravenous infusion. These early cases confirmed the safety of these MSLN targeted CAR-T cells.
In the current proposed feasibility study, the researcher hypothesize that EUS-guided injection of MSLN targeted CAR-T cells into PDAC can induce a tumor response, improve rate of R0 resection and translate into better patient survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSLN CART | Experimental | Other: MSLN CARTEndoscopic ultrasound guided injection of mesothelin-targeted CAR-T cells |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with histologically confirmed pancreatic cancer planned for curative resection.
- Age 18 to 70 years old
- Measurable tumors according to RECIST 1.1s
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- A sufficient number of T cells taken through lymphopheresis (CD3+ T cells>1x109).
Key exclusion criteria (12 listed)
- Patients with AIDS
- Patients with serum HBsAg positive
- The patient has an active or uncontrolled infection.
- Subjects with severe heart, brain, liver, kidney or hematopoietic diseases, or psychosis who are not suitable for surgical resection
- In the first evaluation experiment, expansion ability of T cells activated by Cluster of Differentiation (CD) CD3/CD28 magnetic beads is less than 5 times.
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 |
|---|---|---|
| MSLN CARTEndoscopic ultrasound guided injection of mesothelin-targeted CAR-T cells | Other | MSLN CART |
Primary outcome
pathologic response
Time frame: 3 months
Proportion of major pathologic response on resected specimen of pancreatic tumour
4 secondary outcomes
Radiological response
Time frame: 4 weeks
Rate of R0 surgical resection
Time frame: 3 months
Serious Adverse Event
Time frame: 1 year
Disease free and overall survival
Time frame: 10 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 34547082Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851-862. doi: 10.1001/jama.2021.13027.
- Background: PubMed 36932224Springfeld C, Ferrone CR, Katz MHG, Philip PA, Hong TS, Hackert T, Buchler MW, Neoptolemos J. Neoadjuvant therapy for pancreatic cancer. Nat Rev Clin Oncol. 2023 May;20(5):318-337. doi: 10.1038/s41571-023-00746-1. Epub 2023 Mar 17.
- Background: PubMed 36521500Ghaneh P, Palmer D, Cicconi S, Jackson R, Halloran CM, Rawcliffe C, Sripadam R, Mukherjee S, Soonawalla Z, Wadsley J, Al-Mukhtar A, Dickson E, Graham J, Jiao L, Wasan HS, Tait IS, Prachalias A, Ross P, Valle JW, O'Reilly DA, Al-Sarireh B, Gwynne S, Ahmed I, Connolly K, Yim KL, Cunningham D, Armstrong T, Archer C, Roberts K, Ma YT, Springfeld C, Tjaden C, Hackert T, Buchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. Immediate surgery compared with short-course neoadjuvant gemcitabine plus capecitabine, FOLFIRINOX, or chemoradiotherapy in patients with borderline resectable pancreatic cancer (ESPAC5): a four-arm, multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):157-168. doi: 10.1016/S2468-1253(22)00348-X. Epub 2022 Dec 12.
- BackgroundFietkau R, Ghadimi M, Grützmann R, Wittel UA, Jacobasch L, Uhl W, Croner RS, Bechstein WO, Neumann UP, Waldschmidt D, Boeck SH, Moosmann N, Reinacher-Schick AC, Golcher H, Adler W, Semrau S, Kallies A, Hecht M, Tannapfel A, Oettle H. Randomized phase III trial of induction chemotherapy followed by chemoradiotherapy or chemotherapy alone for nonresectable locally advanced pancreatic cancer: First results of the CONKO-007 trial. J Clin Oncol. 2022;40: issue 16 suppl.4008
- Background: PubMed 23694968Chen SH, Hung WC, Wang P, Paul C, Konstantopoulos K. Mesothelin binding to CA125/MUC16 promotes pancreatic cancer cell motility and invasion via MMP-7 activation. Sci Rep. 2013;3:1870. doi: 10.1038/srep01870.
- Background: PubMed 24334761Kachala SS, Bograd AJ, Villena-Vargas J, Suzuki K, Servais EL, Kadota K, Chou J, Sima CS, Vertes E, Rusch VW, Travis WD, Sadelain M, Adusumilli PS. Mesothelin overexpression is a marker of tumor aggressiveness and is associated with reduced recurrence-free and overall survival in early-stage lung adenocarcinoma. Clin Cancer Res. 2014 Feb 15;20(4):1020-8. doi: 10.1158/1078-0432.CCR-13-1862. Epub 2013 Dec 13.
- Background: PubMed 17785569Hassan R, Bullock S, Premkumar A, Kreitman RJ, Kindler H, Willingham MC, Pastan I. Phase I study of SS1P, a recombinant anti-mesothelin immunotoxin given as a bolus I.V. infusion to patients with mesothelin-expressing mesothelioma, ovarian, and pancreatic cancers. Clin Cancer Res. 2007 Sep 1;13(17):5144-9. doi: 10.1158/1078-0432.CCR-07-0869.
- Background: PubMed 34889852Wang H, Chetty R, Hosseini M, Allende DS, Esposito I, Matsuda Y, Deshpande V, Shi J, Dhall D, Jang KT, Kim GE, Luchini C, Graham RP, Reid MD, Basturk O, Hruban RH, Krasinskas A, Klimstra DS, Adsay V; Pancreatobiliary Pathology Society. Pathologic Examination of Pancreatic Specimens Resected for Treated Pancreatic Ductal Adenocarcinoma: Recommendations From the Pancreatobiliary Pathology Society. Am J Surg Pathol. 2022 Jun 1;46(6):754-764. doi: 10.1097/PAS.0000000000001853. Epub 2021 Dec 15.
- Individual participant dataSharing planned: No
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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.
James Lau, MD principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSLN CART in people with Pancreatic Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 14 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Aug 2024. 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 Hong Kong. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic response (time frame: 3 months). 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 NCT06054308, which also lists 8 linked publications.
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 21 Aug 2024.