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Intrahepatic Cholangiocarcinoma (Icc)Phase 2NCT06648525

Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC

A Phase 2 study testing Adebrelimab, Irinotecan liposomes and Lenvatinib in people with Intrahepatic Cholangiocarcinoma (Icc), run by Harbin Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma (Icc)
What is being tested?
Adebrelimab, Irinotecan liposomes and Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
Oct 2024to Apr 2028
Phase
Phase 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

  • Age: 18 to 75 years old, male or female not limited;
  • Histologically confirmed unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma with measurable tumor lesions (meeting RECIST 1.1 criteria);
  • Have not received systemic anti-tumor treatment in the past;
  • Patients who relapse more than 6 months after curative surgery or after completion of adjuvant therapy (chemotherapy and/or radiotherapy) meet the inclusion criteria;
  • ECOG PS：0-1；
  • Expected survival period ≥ 3 months;
  • The main organ functions are normal, which meets the following criteria:
  • 1) Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): Hemoglobin (Hb) ≥ 85 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 80 × 109/L; 2) Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN; Serum total bilirubin (TBIL) ≤ 3 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min; 3) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; 4) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ 50%; 8. Women of childbearing age must undergo a negative pregnancy test (β HCG) before starting treatment, and women and men of childbearing age (who have sexual relations with women of childbearing age) must agree to continuously use effective contraceptive measures during the treatment period and for 6 months after the last treatment dose; 9. Patients with a history of hepatitis B and C can be included in the study, but active hepatitis B patients must start antiviral therapy before starting the study treatment; 10. Participants voluntarily join the study and sign an informed consent form.

Who cannot join

  • Pregnant or lactating women, or those who have the ability to conceive but refuse to take contraceptive measures;
  • History of other malignant tumors within the past 5 years, excluding cervical carcinoma in situ or squamous cell carcinoma of the skin that has been adequately treated, or basal cell carcinoma of the skin that has been largely controlled;
  • Merge other serious uncontrolled diseases (such as individuals with a history of difficult to control mental illness or severe intellectual or cognitive impairment; severe heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.);
  • Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;
  • Suffering from active, known or suspected autoimmune diseases. Subjects with hypothyroidism who only require hormone replacement therapy and those with skin diseases that do not require systemic treatment may be included;
  • Easy to bleed, at risk of massive hemoptysis, and with a history of significant coagulation dysfunction;
Show all 13Show fewer
  • Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);
  • History of immunodeficiency, including HIV testing positive, having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation and allogeneic bone marrow transplantation;
  • Severe active infections requiring intravenous antibiotic treatment occur during the screening period;
  • Individuals with multiple factors that affect oral medication (such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
  • Individuals who are allergic to the experimental drug;
  • Patients who cannot comply with the trial protocol or cooperate with follow-up;
  • The researchers believe that participants should not participate in this experiment.

Trial locations and contacts

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

Zhiwei Li, MD contact

86+15004683651

lzhw0451@163.com

China1 site

  • Harbin Medical University

    Harbin, Heilongjiang, 150081

    Zhiwei Li, MD, 86+15004683651, lzhw0451@163.com

Other trials in China

About this study

Official title: Adebrelimab Combined with Irinotecan Liposomes, 5-fluorouracil, Calcium Folinate ± Lenvatinib As First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma: a Prospective Clinical Study

This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC).

Read the detailed description

This study plans to recruit 68 patients with unresectable ICC who have not received prior systematic treatment. The patients will be randomly divided into two groups. Group A: patients will receive adebrelimab+irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib; Group B: patients will receive treatment with adebrelimab+irinotecan liposomes+5-fluorouracil+calcium folinate. The combination of irinotecan liposomes+5-fluorouracil+calcium folinate will be used 9 times (Q2W), and adebrelimab ± lenvatinib will be used until disease progression or medication for 2 years.

Being tested
Adebrelimab, Irinotecan liposomes, Lenvatinib, 5-Fluorouracil (5-FU), Calcium Folinate
Keywords
Adebrelimab, Irinotecan liposomes, Lenvatinib, Intrahepatic Cholangiocarcinoma
Medical subject headings
Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension

What participants receive

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

  • AdebrelimabDrug

    Adebrelimab, IV

  • Irinotecan liposomesDrug

    Irinotecan liposomes, IV

  • LenvatinibDrug

    Lenvatinib, po

  • 5-Fluorouracil (5-FU)Drug

    5-Fluorouracil (5-FU), IV

  • Calcium FolinateDrug

    Calcium folinate, IV

Study groups in NCT06648525
Study groupRoleWhat they receive
Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinibExperimentalAdebrelimab in combination with Irinotecan liposomes, 5-fluorouracil, calcium folinate and lenvatinib
Receives: Drug: Adebrelimab; Drug: Irinotecan liposomes; Drug: Lenvatinib; Drug: 5-Fluorouracil (5-FU); Drug: Calcium Folinate
Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinateExperimentalAdebrelimab in combination with Irinotecan liposomes, 5-fluorouracil and calcium folinate
Receives: Drug: Adebrelimab; Drug: Irinotecan liposomes; Drug: 5-Fluorouracil (5-FU); Drug: Calcium Folinate

What is being measured

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

  1. Progression-Free-Survival (PFS)

    The time from enrollment until tumor progression or death from any cause, whichever occurred first

    Measured: up to 24 months

Secondary outcomes (4)

  1. Objective response rate (ORR)

    The proportion of patients with a PR or CR, determined by RECIST v1.1 criteria

    Measured: up to 24 months

  2. Disease control rate (DCR)

    The proportion of patients with a PR, CR, or SD

    Measured: up to 24 months

  3. Overall survival (OS)

    The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date

    Measured: up to 24 months

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Incidence and severity of adverse events graded according to the NCI CTCAE v5.0.

    Measured: up to 24 months

Timeline

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

  1. First posted18 Oct 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06648525
Sponsor's protocol ID
MA-ICC-II-006
Status last verified
Sep 2024
First submitted
12 Sep 2024
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
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 2 study testing Adebrelimab, Irinotecan liposomes and Lenvatinib in people with Intrahepatic Cholangiocarcinoma (Icc), run by Harbin Medical 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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 Oct 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 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?

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 Zhiwei Li, MD (86+15004683651, lzhw0451@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free-Survival (PFS) (time frame: up to 24 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 NCT06648525.

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 18 Oct 2024.

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