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Not yet recruitingNCT06389500Updated Apr 29, 2024

HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

A Phase 2 interventional study of Adebrelimab and Lenvatinib in Biliary Tract Cancer, sponsored by Harbin Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Harbin Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer.

Read the detailed description

This study plans to recruit 30 patients with borderline resectable, locally advanced biliary tract cancer who have not received treatment, abserve and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib.

02

Conditions studied

  • Biliary Tract Cancer

Keywords

  • Adebrelimab
  • Hepatic Arterial Infusion Chemotherapy
  • Lenvatinib
  • Potentially Resectable Biliary Tract Cancer
03

In context

Biliary Tract Neoplasms

484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.

This study's planned enrollment of 30 is below the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.

Browse Biliary Tract Neoplasms studies →

Lead sponsor

Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 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 to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age: 18 to 75 years old, male or female;
  2. Biliary tract malignant tumors confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan ≥10mm, meeting RECIST 1.1 standards);
  3. Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma;
  4. Clinical stage: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma stage: IIIA-IV;
  5. Expected survival > 3 months;
  6. ECOG PS score: 0-1 points;
  7. Liver function classification is Child-Pugh ≤7;
  8. Never received prior systemic treatment for biliary tract tumors;
  9. No peritoneal metastasis or other distant metastasis;
  10. Normal function of major organs;
  11. Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing potential and men (who have sexual active with women of childbearing potential) must agree to effective contraception uninterrupted for the duration of the treatment and for 6 months after the last therapeutic dose;
  12. Patients voluntarily enrolled in the study by signing an informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Patients diagnosed with periampullary cancer;
  2. Previous or concurrent other malignant tumours within 5 years, except cervical carcinoma in situ, cutaneous squamous cell carcinoma or basal cell carcinoma of the skin that has been basically controlled;
  3. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
  4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function;
  5. Suffering from active autoimmune diseases, history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Reduced thyroid function after thyroid hormone replacement therapy can be included;
  6. Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
  7. Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to: 1) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
  8. Severe active infection requiring intravenous antibiotic treatment occurs during the screening period;
  9. Those who are allergic to experimental drugs;
  10. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits;
  11. Those who the researcher believes are not suitable to participate in this trial.
05

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
    HAIC+Immune-targeted therapy

    Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib

    Drug: Adebrelimab · Drug: Lenvatinib · Procedure: Hepatic Arterial Infusion Chemotherapy

Interventions

  • DrugAdebrelimab

    Adebrelimab, IV

    Also known as: SHR-1316

  • DrugLenvatinib

    Lenvatinib, PO

    Also known as: Lenvatinib Mesilate Capsules

  • ProcedureHepatic Arterial Infusion Chemotherapy

    GC regimen±5-FU

06

What researchers measure

Primary outcomes

  1. R0 resection rate

    Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.

    Time frame: up to 24 months

  2. Surgery conversion rate

    Proportion of patients who can undergo surgical resection among all enrolled patients

    Time frame: up to 24 months

Secondary outcomes

  1. Objective response rate

    The proportion of patients whose tumor volume shrinks to a predetermined value and can maintain the minimum time limit, which is the sum of the proportions of complete remission and partial remission.

    Time frame: up to 24 months

  2. pathological complete response rate

    After preoperative treatment and surgery, there are no residual viable tumor cells in the tumor bed in the postoperative specimen (%RVT=0)

    Time frame: up to 24 months

  3. Major pathological response rate

    After preoperative treatment and surgery, the proportion of residual viable tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10% (%RVT≤10)\*

    Time frame: up to 24 months

  4. Recurrence-free survival

    Duration from surgical resection to first recurrence or death from any cause

    Time frame: up to 24 months

  5. Overall survival

    Overall survival is measured from the first dose of study drug until death from any cause.

    Time frame: up to 24 months

  6. AEs

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

    Time frame: up to 24 months

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06389500
Lead sponsor
Harbin Medical University
Responsible party
Yubao Zhang (MD, Harbin Medical University) — Principal investigator
First posted
Apr 29, 2024
Start date
May 1, 2024 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Apr 29, 2024

Study contacts

Yubao Zhang, MD
Contact
zhyb88077@sina.com
+86 139 3658 8077
Yubao Zhang, MD
principal investigator · Harbin Medical University Affiliated Cancer Hospital

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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