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

ConditionIntrahepatic Cholangiocarcinoma (Icc)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHarbin Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab, IV

  • Irinotecan liposomes

    Drug

    Irinotecan liposomes, IV

  • Lenvatinib

    Drug

    Lenvatinib, po

  • 5-Fluorouracil (5-FU)

    Drug

    5-Fluorouracil (5-FU), IV

  • Calcium Folinate

    Drug

    Calcium folinate, IV

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinibExperimental treatment 5 interventions
Group B: Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinateExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-Free-Survival (PFS)

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

Time frame
up to 24 months

Secondary outcomes

1

Objective response rate (ORR)

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

Time frame
up to 24 months
2

Disease control rate (DCR)

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

Time frame
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

Time frame
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.

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harbin Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: