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Advanced Intrahepatic CholangiocarcinomaPhase 1/2NCT06956716

Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma

A Phase 1/2 study testing individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + cisplatin (GP) and Sintilimab injection in people with Advanced Intrahepatic Cholangiocarcinoma, run by Zhejiang University 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
Search all trials

Trial summary

The main purpose of this study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody and standard chemotherapy regimen for the treatment of patients with advanced intrahepatic cholangiocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Intrahepatic Cholangiocarcinoma
What is being tested?
individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + cisplatin (GP) and Sintilimab injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
9 Apr 2025to 1 Apr 2028
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) Subjects who meet all the following inclusion criteria will enter the pre-screening stage of this study and undergo the lesion puncture process:
  • Voluntarily sign the informed consent form;
  • Aged ≥18 years and ≤75 years, regardless of gender;
  • Imaging assessment of unresectable advanced intrahepatic cholangiocarcinoma;
  • Have not received systemic or local treatment.
  • According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assess the lesions as measurable.
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  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Adequate fresh tumor tissue samples can be obtained for exome and transcriptome sequencing analysis;
  • Normal function of the main organs of the heart, liver and kidney:
  • QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men, or ≤470 milliseconds for women;
  • Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;
  • Hematological indicators: white blood cells ≥3.5×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HGB) ≥10 g/dL; platelet count (PLT) ≥80×109/L;
  • Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;
  • Male and female patients of childbearing age with fertility agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of the trial drug; women of childbearing age include premenopausal women and women within 2 years after menopause;
  • Able to follow the study protocol and follow-up procedures.
  • Subjects who meet all the following inclusion criteria will enter the formal screening stage of this study and enter the study medication process:
  • Voluntary signing of the informed consent form;
  • Age ≥ 18 years and ≤ 75 years, regardless of gender;
  • Intrahepatic cholangiocarcinoma confirmed by pathology (histology or cytology);
  • Have not received any systemic treatment.
  • According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assessed the patients as having measurable lesions.
  • The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1;
  • The major organ functions of the heart, liver, and kidney were normal:
  • QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men or ≤470 milliseconds for women;
  • Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;
  • Hematological indicators: white blood cells ≥3.5×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HGB) ≥10 g/dL; platelet count (PLT) ≥80×109/L;
  • Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;
  • Male patients with fertility and female patients of childbearing age agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration of the trial drug; women of childbearing age include premenopausal women and women within 2 years after menopause;
  • Able to follow the study protocol and follow-up process.

Who cannot join

  • If the subject meets any of the following criteria, he/she will be excluded from this study:
  • Those who suffer from other malignant tumors at the same time, but have been cured of basal cell carcinoma, thyroid cancer, cervical atypical hyperplasia, etc., have been in a disease-free state for more than 5 years or are considered by the researchers to be less likely to relapse;
  • Those who have received a history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
  • Those who are accompanied by immunosuppressants, that is, those who need to take immunosuppressants regularly 4 weeks before the screening period and during the clinical study, including but not limited to the following situations: those with severe asthma, autoimmune diseases or immunodeficiency, those who are treated with immunosuppressive drugs, and those with a known history of primary immunodeficiency; but type 1 diabetes, autoimmune-related hypothyroidism requiring hormone treatment, and vitiligo and psoriasis that do not require systemic treatment are excluded;
  • Active bacterial or fungal infection confirmed by clinical diagnosis; active tuberculosis or history of tuberculosis;
  • Positive test results for human immunodeficiency virus (HIV) antibody, positive test results for Treponema pallidum (TP), active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA), active hepatitis B;
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  • Herpes virus infection (except for those with scabs for more than 4 weeks); respiratory virus infection (except for those who have recovered for more than 4 weeks);
  • Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases that the investigator considers unsuitable for inclusion;
  • History of drug abuse, clinical, psychological or social factors that affect informed consent or research implementation; history of mental illness;
  • History of food, drug or vaccine allergy, or other potential immunotherapy allergy considered by the investigator.
  • Pregnant or lactating women;
  • Those who the investigator considers unsuitable for inclusion or may not be able to complete this trial for other reasons.

Trial locations and contacts

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

Tingbo Liang contact

+8619941463683

liangtingbo@zju.edu.cn

China1 site, 1 recruiting

  • the First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Yiwen Chen, +8619941463683, yiwenchen0705@126.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen mRNA Therapy in Combination With PD-1 Antibody and Chemotherapy for Advanced Intrahepatic Cholangiocarcinoma

The main purpose of this study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody and standard chemotherapy regimen for the treatment of patients with advanced intrahepatic cholangiocarcinoma.

Being tested
individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + cisplatin (GP), Sintilimab injection

What participants receive

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

  • individualized anti-tumor new antigen iNeo-Vac-R01 injectionBiological

    The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.

  • Gemcitabine + cisplatin (GP)Drug

    As standard chemotherapy (D1, D8 gemcitabine 1000mg/m², intravenous drip for 30 minutes, cisplatin 25mg/m², intravenous drip), once every 3 weeks

  • Sintilimab injectionDrug

    Sintilimab Injection, 200mg, intravenous infusion

Study groups in NCT06956716
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection; Drug: Gemcitabine + cisplatin (GP); Drug: Sintilimab injection

What is being measured

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

  1. Safety and tolerable dose

    According to the Commonly Used Adverse Events Criteria (CTCAE Version 5.0), the number of subjects with adverse events and/or dose-limiting toxicity was counted as an indicator of the safety and tolerable dose of iNeo-Vac-R01 injection. The evaluation period was the dosing observation period and the safety follow-up period.

    Measured: 21±3 days after the last dose

Secondary outcomes (5)

  1. Objective reponse rate (ORR)

    The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.

    Measured: Up to 2 years

  3. Progression-free survival （PFS）

    The time from enrolled to disease pregression or death from any cause during the whole study.

    Measured: Up to 2 years

  4. Overall survival (OS)

    The time from enrolled to death from any cause during the whole study.

    Measured: Up to 2 years

  5. Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%)

    The percentage of patients surviving at 12, 24, and 36 months.

    Measured: Up to 3 years

Timeline

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

  1. First posted4 May 2025
  2. Study start9 Apr 2025
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956716
Sponsor's protocol ID
CISLD-14
Status last verified
Apr 2025
First submitted
9 Apr 2025
Last updated
4 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + cisplatin (GP) and Sintilimab injection in people with Advanced Intrahepatic Cholangiocarcinoma, run by Zhejiang University 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 29 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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 Tingbo Liang (+8619941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerable dose (time frame: 21±3 days after the last dose). 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 NCT06956716.

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 4 May 2025.

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