Adrenal Cortical CarcinomaNCT06141369

Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)

A study testing individualized mRNA neoantigen vaccine (mRNA-0523-L001) in people with Adrenal Cortical Carcinoma and Medullary Thyroid Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Adrenal Cortical Carcinoma, Medullary Thyroid Cancer, Thymic Neuroendocrine Carcinoma
What is being tested?: individualized mRNA neoantigen vaccine (mRNA-0523-L001)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteChina
Study dates: 13 Jan 2024to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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

The subjects voluntarily sign the written informed consent form and can comply with the visits and related procedures specified in the protocol;
The subjects are 18 years old or older, regardless of gender;
Patients with advanced endocrine tumors confirmed by histology or cytology in the past 6 months (including medullary thyroid carcinoma, thymic carcinoma and adrenal cortical carcinoma, etc.), who have failed standard treatment or have no standard treatment available;
No HLA-related genes or chromosomal regions with copy number variations (CNVs) or loss of heterozygosity (LOH) were detected by gene sequencing;
They have advanced or metastatic lesions confirmed by immunohistochemistry, and have frozen tissue/cells sufficient for WES and RNAseq sequencing, and after bioinformatics analysis, they predict at least one antigen that is effectively presented by their own HLA, such as KRAS or TP53 mutations and corresponding HLA typing, see 1.4 for the rationale of the topic.
Expected survival ≥ 4 months;

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According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), they have at least one measurable lesion, which should not have received local treatment such as radiotherapy (lesions in the previous radiotherapy area, if confirmed to have progressed, can also be selected as target lesions);
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;
They have not used granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion or platelet transfusion within 14 days before the examination.
Subjects of childbearing potential (male and female) who meet the inclusion criteria must agree to use reliable contraception methods (hormonal or barrier methods or abstinence) during the trial and for at least 90 days after the last administration; women of childbearing age must have a negative blood pregnancy test within 7 days before the first administration.
Virology test: No CMV, EBV, HIV, HBV, HCV, syphilis infection (only at baseline)

Who cannot join

Received chemotherapy, hormone therapy, traditional Chinese medicine with anti-tumor indications or other anti-tumor treatments within 4 weeks before the first administration (for mitomycin and nitrosourea, the last administration was within 6 weeks before the first administration of this study drug), or within 5 half-lives of immunotherapy or molecular targeted therapy;
Received other major surgery other than diagnosis or biopsy within 4 weeks before the first administration, or expected to receive major surgery during the study;
Patients who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or plan to receive organ transplantation during this study;
Patients who have received other tumor vaccines or cell therapies in the past; Medical condition
Patients with clinically symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence indicating that the patient's brain or spinal cord metastases are not controlled, and are deemed unsuitable for enrollment by the investigator;
In the past 2 years, there have been known other malignant tumors that are progressing or require active treatment (except for non-melanoma skin cancer, superficial bladder cancer, and cervical carcinoma in situ that have been cured by radical surgery);

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Have a history of interstitial lung disease (ILD) or pulmonary interstitial fibrosis;
Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: a) Have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block; corrected QTc interval male > 450 milliseconds, female > 470 milliseconds, b) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first administration, c) New York Heart Association (NYHA) ≥ III grade heart failure or left ventricular ejection fraction (LVEF) <50%.
Other serious and/or uncontrollable diseases that may affect the subject's participation in this study, as determined by the investigator, including but not limited to: a) Have a history of severe drug allergy, or known to be allergic to any component of the tumor vaccine; or have had a severe allergic reaction to other monoclonal antibodies in the past, b) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, c) Evidence of severe or uncontrolled liver or kidney disease, d) Poorly controlled hypertension, diabetes, etc., e) Patients with active ulcers or gastrointestinal bleeding f) Have a severe infection that requires intravenous infusion of antibiotics or hospitalization; or uncontrolled active infection within 4 weeks before the first administration, g) Have active syphilis infection.
Participated in other clinical trials within 4 weeks before the first administration (except for screening failure);
Currently receiving systemic use of corticosteroids (except for recent or current use of inhaled corticosteroids);
Pregnant or lactating women; Laboratory and imaging examinations
Imaging (CT or MRI) shows that the tumor invades the large blood vessels and has a tendency to bleed;
Have clinically significant thyroid function abnormalities, and the investigator deems them unsuitable for enrollment;
Active pneumonia was found in the screening chest CT scan;
Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
The adverse reactions of previous anti-tumor treatment have not recovered to NCI-CTCAE 5.0 grade evaluation ≤ 1 (except for hair loss);
Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) test value higher than the upper limit of normal; hepatitis C virus antibody (HCV Ab) positive and HCV RNA test value higher than the upper limit of normal; Investigator assessment
The investigator considers that there are other reasons that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lei Ye contact

Luming Wu contact

China1 site, 1 recruiting

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Guang Ning, Professor, 8621-64370045 ext. 665344, ljl11319@rjh.com.cn
Guang Ning, Professor
Recruiting

Other trials in China

About this study

Treatment of advanced endocrine tumors, including adrenal corticocarcnioma (ACC), medullary thyroid carcinoma (MTC), thymic neuroendocrine tumor and pancreatic neuroendocrine tumor is challenging. Previous genomic profiling studies showed they presented a number of somatic mutations. The tumors Individualized mRNA neoantigen vaccine provide a promising solution since a significant portion of these tumors showed high quality of tumor specific neoantigen. The primary objective is to observe and evaluate the safety and tolerability of individualized mRNA neoantigen vaccine (mRNA-0523-L001) for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available. The secondary objective is to observe the preliminary efficacy of mRNA-0523-L001 for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available, including:

Neoantigen-specific CD4+ and CD8+ T lymphocyte responses induced by mRNA-0523-L001;
Objective response rate (ORR) and disease control rate (DCR) of tumors;
Progression-free survival (PFS).

Conditions: Adrenal Cortical Carcinoma, Medullary Thyroid Cancer, Thymic Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Tumor
Being tested: individualized mRNA neoantigen vaccine (mRNA-0523-L001)
Medical subject headings: Adrenocortical Carcinoma, Carcinoma, Medullary, Adenoma, Islet Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

individualized mRNA neoantigen vaccine (mRNA-0523-L001)Biological
Individualized mRNA neoantigen vaccine (mRNA-0523-L001) will be injected intramuscularly every 21 days for 9 cycles. Dose escalation will be administered in 3 patients. 18 additional patients will be recruited and administered at the maximum tolerated(MTD) dose for all nine cycles. Injection of mRNA-0523-L001 will continue if an objective response is observed until the discontinuation criteria are met.

Study groups in NCT06141369
Study group	Role	What they receive
mRNA-0523-L001	Experimental	individualized mRNA neoantigen vaccine (mRNA-0523-L001) Receives: Biological: individualized mRNA neoantigen vaccine (mRNA-0523-L001)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum tolerated dose (MTD) or Dose-limiting toxicity (DLT).If MTD is not reached, Biologically Effective Dose (BED)tumor neoantigen.
The highest dose of a drug or treatment that does not cause unacceptable side effects.
Measured: At the end of cycle 1(each cycle is 21 days)
Incidence of treatment-related adverse events.
According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Measured: At the end of cycle 1(each cycle is 21 days)

Secondary outcomes (4)

Reaction of antigen-specific T cells in peripheral blood.
mRNA-0523-L001 personalized tumor vaccine induces neoantigen specific CD4+and CD8+T lymphocyte responses.
Measured: At the end of cycle 1(each cycle is 21 days)
Objective tumor response rate (ORR)
ORR calculates the ratio of the number of patients whose best response is complete remission (CR) or partial remission (PR) to the total number of evaluable patients according to RECIST 1.1 criteria. Those who have not been evaluated for lesion and tumor response will be regarded as non-evaluable patients and will not be counted.
Measured: At the end of cycle 1(each cycle is 21 days)
Disease control rate (DCR)
DCR calculates the ratio of the number of patients whose best response is complete remission (CR), or partial remission (PR), or stable disease (SD) to the total number of evaluable patients according to RECIST 1.1 criteria. Those who have not been evaluated for lesion and tumor response will be regarded as non-evaluable patients and will not be counted.
Measured: At the end of cycle 1(each cycle is 21 days)
Progressive free survival (PFS)
Progression-free Survival of Personalized mRNA Tumor Vaccine.
Measured: At the end of cycle 1(each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202430 Jun 2027

First posted21 Nov 2023
Study start13 Jan 2024
Primary completion30 Dec 2026 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Adrenal Cortical CarcinomaStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe 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: 21 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06141369
Sponsor's protocol ID: KY2023-161
Status last verified: Apr 2026
First submitted: 13 Nov 2023
Last updated: 9 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hofland J, Kaltsas G, de Herder WW. Advances in the Diagnosis and Management of Well-Differentiated Neuroendocrine Neoplasms. Endocr Rev. 2020 Apr 1;41(2):371-403. doi: 10.1210/endrev/bnz004.
PubMed 31555796
Saltiki K, Simeakis G, Karapanou O, Alevizaki M. MANAGEMENT OF ENDOCRINE DISEASE: Medullary thyroid cancer: from molecular biology and therapeutic pitfalls to future targeted treatment perspectives. Eur J Endocrinol. 2022 Jul 26;187(3):R53-R63. doi: 10.1530/EJE-22-0312. Print 2022 Sep 1.
PubMed 35895692
Fazzari F, Mantovani R, Donghi V, Curzi M, Bragato RM. From EACVI recommendations to the real-world experience: safety of performing echocardiography in the pandemic era. Eur Heart J Cardiovasc Imaging. 2021 Jun 22;22(7):e82-e83. doi: 10.1093/ehjci/jeab010. No abstract available.
PubMed 33491077
Ciampi R, Romei C, Ramone T, Prete A, Tacito A, Cappagli V, Bottici V, Viola D, Torregrossa L, Ugolini C, Basolo F, Elisei R. Genetic Landscape of Somatic Mutations in a Large Cohort of Sporadic Medullary Thyroid Carcinomas Studied by Next-Generation Targeted Sequencing. iScience. 2019 Oct 25;20:324-336. doi: 10.1016/j.isci.2019.09.030. Epub 2019 Sep 26.
PubMed 31605946
Tran E, Robbins PF, Rosenberg SA. 'Final common pathway' of human cancer immunotherapy: targeting random somatic mutations. Nat Immunol. 2017 Feb 15;18(3):255-262. doi: 10.1038/ni.3682.
PubMed 28198830
Parikh AR, Mojtahed A, Schneider JL, Kanter K, Van Seventer EE, Fetter IJ, Thabet A, Fish MG, Teshome B, Fosbenner K, Nadres B, Shahzade HA, Allen JN, Blaszkowsky LS, Ryan DP, Giantonio B, Goyal L, Nipp RD, Roeland E, Weekes CD, Wo JY, Zhu AX, Dias-Santagata D, Iafrate AJ, Lennerz JK, Hong TS, Siravegna G, Horick N, Clark JW, Corcoran RB. Serial ctDNA Monitoring to Predict Response to Systemic Therapy in Metastatic Gastrointestinal Cancers. Clin Cancer Res. 2020 Apr 15;26(8):1877-1885. doi: 10.1158/1078-0432.CCR-19-3467. Epub 2020 Jan 15.
PubMed 31941831
Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
PubMed 25014687
Molina AM, Hu J, Nanus DM. Is Underutilization of Cytoreductive Nephrectomy in Patients With Metastatic Renal Cancer Contributing to Inferior Survival? J Clin Oncol. 2016 Sep 20;34(27):3235-6. doi: 10.1200/JCO.2016.68.4050. Epub 2016 Aug 15. No abstract available.
PubMed 27528717
Ye L, Santarpia L, Gagel RF. The evolving field of tyrosine kinase inhibitors in the treatment of endocrine tumors. Endocr Rev. 2010 Aug;31(4):578-99. doi: 10.1210/er.2009-0031. Epub 2010 Jul 6.
PubMed 20605972
Anand S, Shivashankar R, Kondal D, Garg V, Khandelwal S, Gupta R, Krishnan A, Amarchand R, Poulter N, Reddy KS, Prabhakaran D, Mohan S. Potassium Intake in India: Opportunity for Mitigating Risks of High-Sodium Diets. Am J Prev Med. 2020 Feb;58(2):302-312. doi: 10.1016/j.amepre.2019.09.017.
PubMed 31959324
Fassnacht M, Terzolo M, Allolio B, Baudin E, Haak H, Berruti A, Welin S, Schade-Brittinger C, Lacroix A, Jarzab B, Sorbye H, Torpy DJ, Stepan V, Schteingart DE, Arlt W, Kroiss M, Leboulleux S, Sperone P, Sundin A, Hermsen I, Hahner S, Willenberg HS, Tabarin A, Quinkler M, de la Fouchardiere C, Schlumberger M, Mantero F, Weismann D, Beuschlein F, Gelderblom H, Wilmink H, Sender M, Edgerly M, Kenn W, Fojo T, Muller HH, Skogseid B; FIRM-ACT Study Group. Combination chemotherapy in advanced adrenocortical carcinoma. N Engl J Med. 2012 Jun 7;366(23):2189-97. doi: 10.1056/NEJMoa1200966. Epub 2012 May 2.
PubMed 22551107
Nolan CR, Linas SL. Mechanism of antihypertensive effect of potassium depletion in renovascular hypertension. Am J Physiol. 1988 Nov;255(5 Pt 2):H1181-7. doi: 10.1152/ajpheart.1988.255.5.H1181.
PubMed 3056041
Trotman J, Opat S, Gottlieb D, Simpson D, Marlton P, Cull G, Munoz J, Tedeschi A, Roberts AW, Seymour JF, Atwal SK, Yu Y, Novotny W, Holmgren E, Tan Z, Hilger JD, Huang J, Tam CS. Zanubrutinib for the treatment of patients with Waldenstrom macroglobulinemia: 3 years of follow-up. Blood. 2020 Oct 29;136(18):2027-2037. doi: 10.1182/blood.2020006449.
PubMed 32698195
Ferraro AJ. The Many Fictions of Illness: A Rhetorical Approach to Understanding Fictionality in Mom's Cancer. Lit Med. 2021;39(2):227-248. doi: 10.1353/lm.2021.0022.
PubMed 34897126
REMAP-CAP Investigators; Gordon AC, Mouncey PR, Al-Beidh F, Rowan KM, Nichol AD, Arabi YM, Annane D, Beane A, van Bentum-Puijk W, Berry LR, Bhimani Z, Bonten MJM, Bradbury CA, Brunkhorst FM, Buzgau A, Cheng AC, Detry MA, Duffy EJ, Estcourt LJ, Fitzgerald M, Goossens H, Haniffa R, Higgins AM, Hills TE, Horvat CM, Lamontagne F, Lawler PR, Leavis HL, Linstrum KM, Litton E, Lorenzi E, Marshall JC, Mayr FB, McAuley DF, McGlothlin A, McGuinness SP, McVerry BJ, Montgomery SK, Morpeth SC, Murthy S, Orr K, Parke RL, Parker JC, Patanwala AE, Pettila V, Rademaker E, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Sligl WI, Turgeon AF, Turner AM, van de Veerdonk FL, Zarychanski R, Green C, Lewis RJ, Angus DC, McArthur CJ, Berry S, Webb SA, Derde LPG. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Apr 22;384(16):1491-1502. doi: 10.1056/NEJMoa2100433. Epub 2021 Feb 25.
PubMed 33631065

Interested in taking part?

Lei Ye

15201909962

lei_yelei@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
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Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma
RecruitingObservational study
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All Adrenal Cortical Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)
ClinicalTrials.gov ID: NCT06141369
Acronym / sponsor ID: KY2023-161
Conditions: Adrenal Cortical Carcinoma, Medullary Thyroid Cancer, Thymic Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Tumor
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 21 participants (estimated)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 13 Jan 2024 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 21 Nov 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.

Neoantigen-specific CD4+ and CD8+ T lymphocyte responses induced by mRNA-0523-L001;
Objective response rate (ORR) and disease control rate (DCR) of tumors;
Progression-free survival (PFS).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
mRNA-0523-L001	Experimental	Biological: individualized mRNA neoantigen vaccine (mRNA-0523-L001)individualized mRNA neoantigen vaccine (mRNA-0523-L001)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

The subjects voluntarily sign the written informed consent form and can comply with the visits and related procedures specified in the protocol;
The subjects are 18 years old or older, regardless of gender;
Patients with advanced endocrine tumors confirmed by histology or cytology in the past 6 months (including medullary thyroid carcinoma, thymic carcinoma and adrenal cortical carcinoma, etc.), who have failed standard treatment or have no standard treatment available;
No HLA-related genes or chromosomal regions with copy number variations (CNVs) or loss of heterozygosity (LOH) were detected by gene sequencing;
They have advanced or metastatic lesions confirmed by immunohistochemistry, and have frozen tissue/cells sufficient for WES and RNAseq sequencing, and after bioinformatics analysis, they predict at least one antigen that is effectively presented by their own HLA, such as KRAS or TP53 mutations and corresponding HLA typing, see 1.4 for the rationale of the topic.

Key exclusion criteria (19 listed)

Received chemotherapy, hormone therapy, traditional Chinese medicine with anti-tumor indications or other anti-tumor treatments within 4 weeks before the first administration (for mitomycin and nitrosourea, the last administration was within 6 weeks before the first administration of this study drug), or within 5 half-lives of immunotherapy or molecular targeted therapy;
Received other major surgery other than diagnosis or biopsy within 4 weeks before the first administration, or expected to receive major surgery during the study;
Patients who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or plan to receive organ transplantation during this study;
Patients who have received other tumor vaccines or cell therapies in the past; Medical condition
Patients with clinically symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence indicating that the patient's brain or spinal cord metastases are not controlled, and are deemed unsuitable for enrollment by the investigator;

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
individualized mRNA neoantigen vaccine (mRNA-0523-L001)Individualized mRNA neoantigen vaccine (mRNA-0523-L001) will be injected intramuscularly every 21 days for 9 cycles. Dose escalation will be administered in 3 patients. 18 additional patients will be recruited and administered at the maximum tolerated(MTD) dose for all nine cycles. Injection of mRNA-0523-L001 will continue if an objective response is observed until the discontinuation criteria are met.	Biological	mRNA-0523-L001

Primary outcome

Maximum tolerated dose (MTD) or Dose-limiting toxicity (DLT).If MTD is not reached, Biologically Effective Dose (BED)tumor neoantigen.
Time frame: At the end of cycle 1(each cycle is 21 days)
The highest dose of a drug or treatment that does not cause unacceptable side effects.
Incidence of treatment-related adverse events.
Time frame: At the end of cycle 1(each cycle is 21 days)
According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

4 secondary outcomes

Reaction of antigen-specific T cells in peripheral blood.
Time frame: At the end of cycle 1(each cycle is 21 days)
Objective tumor response rate (ORR)
Time frame: At the end of cycle 1(each cycle is 21 days)
Disease control rate (DCR)
Time frame: At the end of cycle 1(each cycle is 21 days)
Progressive free survival (PFS)
Time frame: At the end of cycle 1(each cycle is 21 days)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
Background: PubMed 31555796Hofland J, Kaltsas G, de Herder WW. Advances in the Diagnosis and Management of Well-Differentiated Neuroendocrine Neoplasms. Endocr Rev. 2020 Apr 1;41(2):371-403. doi: 10.1210/endrev/bnz004.
Background: PubMed 35895692Saltiki K, Simeakis G, Karapanou O, Alevizaki M. MANAGEMENT OF ENDOCRINE DISEASE: Medullary thyroid cancer: from molecular biology and therapeutic pitfalls to future targeted treatment perspectives. Eur J Endocrinol. 2022 Jul 26;187(3):R53-R63. doi: 10.1530/EJE-22-0312. Print 2022 Sep 1.
Background: PubMed 33491077Fazzari F, Mantovani R, Donghi V, Curzi M, Bragato RM. From EACVI recommendations to the real-world experience: safety of performing echocardiography in the pandemic era. Eur Heart J Cardiovasc Imaging. 2021 Jun 22;22(7):e82-e83. doi: 10.1093/ehjci/jeab010. No abstract available.
Background: PubMed 31605946Ciampi R, Romei C, Ramone T, Prete A, Tacito A, Cappagli V, Bottici V, Viola D, Torregrossa L, Ugolini C, Basolo F, Elisei R. Genetic Landscape of Somatic Mutations in a Large Cohort of Sporadic Medullary Thyroid Carcinomas Studied by Next-Generation Targeted Sequencing. iScience. 2019 Oct 25;20:324-336. doi: 10.1016/j.isci.2019.09.030. Epub 2019 Sep 26.
Background: PubMed 28198830Tran E, Robbins PF, Rosenberg SA. 'Final common pathway' of human cancer immunotherapy: targeting random somatic mutations. Nat Immunol. 2017 Feb 15;18(3):255-262. doi: 10.1038/ni.3682.
Background: PubMed 31941831Parikh AR, Mojtahed A, Schneider JL, Kanter K, Van Seventer EE, Fetter IJ, Thabet A, Fish MG, Teshome B, Fosbenner K, Nadres B, Shahzade HA, Allen JN, Blaszkowsky LS, Ryan DP, Giantonio B, Goyal L, Nipp RD, Roeland E, Weekes CD, Wo JY, Zhu AX, Dias-Santagata D, Iafrate AJ, Lennerz JK, Hong TS, Siravegna G, Horick N, Clark JW, Corcoran RB. Serial ctDNA Monitoring to Predict Response to Systemic Therapy in Metastatic Gastrointestinal Cancers. Clin Cancer Res. 2020 Apr 15;26(8):1877-1885. doi: 10.1158/1078-0432.CCR-19-3467. Epub 2020 Jan 15.
Background: PubMed 25014687Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
Background: PubMed 27528717Molina AM, Hu J, Nanus DM. Is Underutilization of Cytoreductive Nephrectomy in Patients With Metastatic Renal Cancer Contributing to Inferior Survival? J Clin Oncol. 2016 Sep 20;34(27):3235-6. doi: 10.1200/JCO.2016.68.4050. Epub 2016 Aug 15. No abstract available.
Background: PubMed 20605972Ye L, Santarpia L, Gagel RF. The evolving field of tyrosine kinase inhibitors in the treatment of endocrine tumors. Endocr Rev. 2010 Aug;31(4):578-99. doi: 10.1210/er.2009-0031. Epub 2010 Jul 6.
Background: PubMed 31959324Anand S, Shivashankar R, Kondal D, Garg V, Khandelwal S, Gupta R, Krishnan A, Amarchand R, Poulter N, Reddy KS, Prabhakaran D, Mohan S. Potassium Intake in India: Opportunity for Mitigating Risks of High-Sodium Diets. Am J Prev Med. 2020 Feb;58(2):302-312. doi: 10.1016/j.amepre.2019.09.017.
Background: PubMed 22551107Fassnacht M, Terzolo M, Allolio B, Baudin E, Haak H, Berruti A, Welin S, Schade-Brittinger C, Lacroix A, Jarzab B, Sorbye H, Torpy DJ, Stepan V, Schteingart DE, Arlt W, Kroiss M, Leboulleux S, Sperone P, Sundin A, Hermsen I, Hahner S, Willenberg HS, Tabarin A, Quinkler M, de la Fouchardiere C, Schlumberger M, Mantero F, Weismann D, Beuschlein F, Gelderblom H, Wilmink H, Sender M, Edgerly M, Kenn W, Fojo T, Muller HH, Skogseid B; FIRM-ACT Study Group. Combination chemotherapy in advanced adrenocortical carcinoma. N Engl J Med. 2012 Jun 7;366(23):2189-97. doi: 10.1056/NEJMoa1200966. Epub 2012 May 2.
Background: PubMed 3056041Nolan CR, Linas SL. Mechanism of antihypertensive effect of potassium depletion in renovascular hypertension. Am J Physiol. 1988 Nov;255(5 Pt 2):H1181-7. doi: 10.1152/ajpheart.1988.255.5.H1181.
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.

Lei Ye contact

Luming Wu contact

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Ye (15201909962, lei_yelei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) or Dose-limiting toxicity (DLT).If MTD is not reached, Biologically Effective Dose (BED)tumor neoantigen. (time frame: At the end of cycle 1(each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 NCT06141369, which also lists 27 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 9 Apr 2026.