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

NCT06648525 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-ICC-II-006
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Keywords

Adebrelimab; Irinotecan liposomes; Lenvatinib; Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

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

  up to 24 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  up to 24 months

• Disease control rate (DCR)

  up to 24 months

• Overall survival (OS)

  up to 24 months

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

  up to 24 months

Study Arms (2)

Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib

EXPERIMENTAL

Adebrelimab in combination with Irinotecan liposomes, 5-fluorouracil, calcium folinate and lenvatinib

Drug: Adebrelimab; Drug: Irinotecan liposomes; Drug: Lenvatinib; Drug: 5-Fluorouracil (5-FU); Drug: Calcium Folinate

Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate

EXPERIMENTAL

Adebrelimab in combination with Irinotecan liposomes, 5-fluorouracil and calcium folinate

Drug: Adebrelimab; Drug: Irinotecan liposomes; Drug: 5-Fluorouracil (5-FU); Drug: Calcium Folinate

Interventions

Adebrelimab DRUG

Adebrelimab, IV

Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib; Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate

Irinotecan liposomes DRUG

Irinotecan liposomes, IV

Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib; Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate

Lenvatinib DRUG

Lenvatinib, po

Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib

5-Fluorouracil (5-FU) DRUG

5-Fluorouracil (5-FU), IV

Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib; Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate

Calcium Folinate DRUG

Calcium folinate, IV

Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib; Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ECOG PS：0-1；
• Expected survival period ≥ 3 months;
• The main organ functions are normal, which meets the following criteria:
• \) 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

lenvatinib; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Zhiwei Li, MD

CONTACT

86+15004683651; lzhw0451@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the gastroenterology ward

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 18, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)