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Not yet recruitingNCT06375642Updated Apr 19, 2024

A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC

A Phase 2 interventional study of Adebrelimab in Intrahepatic Cholangiocarcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs.

Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma.

Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma.

Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells.

Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R.

This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options.

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Conditions studied

  • Intrahepatic Cholangiocarcinoma

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03

In context

Cholangiocarcinoma

913 studies on the registry are indexed under Cholangiocarcinoma; 285 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 686 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Sign a written informed consent form before enrollment;
  2. Age > 18 years, both men and women;
  3. Patients with histologically or pathologically confirmed intrahepatic cholangiocarcinoma;
  4. No previous systemic therapy and local therapy;
  5. Measurable intrahepatic lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of non-lymph node lesions is ≥ 10 mm, and the short diameter of CT scan of lymph node lesions is ≥ 15 mm);
  6. ECOG PS score: 0-1;
  7. Expected survival greater than 12 weeks;
  8. Vital organs function in accordance with the following requirements (excluding any blood components and cell growth factors used within 14 days):
  1. Blood routine: Neutrophils ≥ 1.5 × 109/L; Platelet count ≥ 60 × 109/L;Hemoglobin ≥ 90 g/L; 2) Hepatic and renal function: Serum creatinine (SCr) ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);Total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN);Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 10 times the upper limit of normal (ULN); urine protein \< 2 +; if urine protein ≥ 2 +, 24-hour urine protein quantification must show protein ≤ 1 g; 9. Normal coagulation function, no active bleeding and thrombosis disease
  1. International normalized ratio INR ≤ 1.5 × ULN;
  2. Partial thromboplastin time APTT ≤ 1.5 × ULN;
  3. PT ≤ 1.5 × ULN; 10. Non-surgically sterilized or female patients of childbearing age need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment and within 3 months after the end of study treatment; non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before study enrollment; and must be non-lactating; non-surgically sterilized or male patients of childbearing age need to agree to use a medically recognized contraceptive during study treatment and within 3 months after the end of study treatment with their spouses.
  1. The subject voluntarily joins this study, has good compliance, and cooperates with safety and survival follow-up

Exclusion criteria

Exclusion Criteria:

  1. The subject has previous or concurrent other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
  2. Previous immunotherapy except anti-PD-1/PD-L1 monoclonal antibody; known subject has previously been allergic to macromolecular protein preparations, or known hypersensitivity to the applied drug components;
  3. Subjects with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery can not be included; subjects with vitiligo or childhood asthma has been completely relieved, no intervention is required after adults can be included; subjects with asthma requiring bronchodilators for medical intervention can not be included);
  4. Subjects are using immunosuppressive agents, or systemic, or absorbable local hormone therapy to achieve immunosuppressive purposes (dose > 10 mg/day prednisone or other effective hormones), and continue to use within 2 weeks before enrollment;
  5. Ascites or pleural effusion with clinical symptoms, ascites requiring therapeutic puncture or regular drainage (≥ 1 time/month);
  6. Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
  7. The subject has active infection or unexplained fever > 38.5 degrees during screening or before the first dose (the subject can be enrolled due to fever caused by the tumor as judged by the investigator);
  8. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function;
  9. Subjects with congenital or acquired immunodeficiency, such as HIV infection;
  10. Live vaccines less than 4 weeks before study drug or likely during the study;
  11. The subject has a known history of psychiatric drug abuse, alcoholism or drug abuse;
  12. Patients who cannot be orally administered;
  13. Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose.
  14. The investigator believes that the subject should be excluded from this study, for example, the investigator judges that the subject has other factors that may cause forced halfway termination of this study, for example, other serious diseases (including mental illness) require concomitant treatment, severe gastroesophageal varices, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subject, or the collection of data and samples.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Study arm

    Surufatinib: 100 mg orally qd, Adebrelimab: 1200 mg, IV, q3w, HAIC: Irinotecan liposome 30 mg/m2, leucovorin 200 mg/m2, 5-FU 200 mg/m2 bolus followed by continuous infusion of 5-FU 1200 mg/m2 5-FU q3W for 24 h. Dose adjustment was allowed for instilled drugs during treatment, and delayed administration was allowed for up to 8 weeks, calculated from the last administration time, otherwise treatment was terminated. Tumor assessment will be performed by imaging method every 3 cycles (± 7 days) in 21-day cycles until disease progression (RECIST 1.1) or death (during treatment), and tumor treatment and survival status after disease progression will be recorded.

    Drug: Adebrelimab

Interventions

  • DrugAdebrelimab

    Adebrelimab, Surufatinib and HAIC

    Also known as: Surufatinib, HAIC

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What researchers measure

Primary outcomes

  1. Objective Response Rate

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease(PD), using RECIST v1.1

    Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year

  2. Disease Control Rate

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease(PD), using RECIST v1.1

    Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year

Secondary outcomes

  1. Overall Survival

    every two months follow up after EOT observation period at 30 days after the last medication

    Time frame: from treatment initiation until death due to any cause, assessed up to 3 year

  2. Progress-Free Survival

    every two months follow up after EOT observation period at 30 days after the last medication

    Time frame: from treatment initiation until death due to any cause, assessed up to 2 year

  3. Incidence and severity of AE and SAE

    Safety

    Time frame: from first dose to 30 days post the last dose

  4. Dose suspension rate caused by adverse events

    Safety

    Time frame: from first dose to 30 days post the last dose

  5. dose termination rate caused by adverse events

    Safety

    Time frame: from first dose to 30 days post the last dose

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Study locations

1 site
  • Tianjin Cancer Hospital Airport Hospital
    Tianjin, Tianjin 300308, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06375642
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
HuiKai Li (Chief Physician, Tianjin Medical University Cancer Institute and Hospital) — Principal investigator
First posted
Apr 19, 2024
Start date
May 10, 2024 (estimated)
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Apr 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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