Biliary Tract CancerPhase 2NCT06389500
HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer
A Phase 2 study testing Adebrelimab, Lenvatinib and Hepatic Arterial Infusion Chemotherapy in people with Biliary Tract Cancer, run by Harbin Medical University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Adebrelimab, Lenvatinib and Hepatic Arterial Infusion Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 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;
- Biliary tract malignant tumors confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan ≥10mm, meeting RECIST 1.1 standards);
- Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma;
- Clinical stage: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma stage: IIIA-IV;
- Expected survival > 3 months;
- ECOG PS score: 0-1 points;
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- Liver function classification is Child-Pugh ≤7;
- Never received prior systemic treatment for biliary tract tumors;
- No peritoneal metastasis or other distant metastasis;
- Normal function of major organs;
- 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;
- Patients voluntarily enrolled in the study by signing an informed consent form.
Who cannot join
- Patients diagnosed with periampullary cancer;
- 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;
- Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
- Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function;
- 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;
- 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;
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- 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;
- Severe active infection requiring intravenous antibiotic treatment occurs during the screening period;
- Those who are allergic to experimental drugs;
- Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits;
- Those who the researcher believes are not suitable to participate in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab and Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer: a Single-arm, Exploratory Clinical Study
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.
- Conditions
- Biliary Tract Cancer
- Being tested
- Adebrelimab, Lenvatinib, Hepatic Arterial Infusion Chemotherapy
- Keywords
- Adebrelimab, Hepatic Arterial Infusion Chemotherapy, Lenvatinib, Potentially Resectable Biliary Tract Cancer
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316
Adebrelimab, IV
LenvatinibDrug
Also called Lenvatinib Mesilate Capsules
Lenvatinib, PO
Hepatic Arterial Infusion ChemotherapyProcedure or surgery
GC regimen±5-FU
| Study group | Role | What they receive |
|---|---|---|
| HAIC+Immune-targeted therapy | Experimental | Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib Receives: Drug: Adebrelimab; Drug: Lenvatinib; Procedure: Hepatic Arterial Infusion Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.
Measured: up to 24 months
Surgery conversion rate
Proportion of patients who can undergo surgical resection among all enrolled patients
Measured: up to 24 months
Secondary outcomes (6)
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.
Measured: up to 24 months
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)
Measured: up to 24 months
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)*
Measured: up to 24 months
Recurrence-free survival
Duration from surgical resection to first recurrence or death from any cause
Measured: up to 24 months
Overall survival
Overall survival is measured from the first dose of study drug until death from any cause.
Measured: up to 24 months
AEs
Incidence, nature, 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.
- First posted29 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yubao Zhang, Harbin Medical University
- Investigators
- Yubao Zhang, MD, Principal investigator, Harbin Medical University Affiliated Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389500
- Sponsor's protocol ID
- SHR-1316-HLJ-006
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab and Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer: a Single-arm, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06389500
- Acronym / sponsor ID
- SHR-1316-HLJ-006
- Conditions
- Biliary Tract Cancer
- Keywords
- Adebrelimab, Hepatic Arterial Infusion Chemotherapy, Lenvatinib, Potentially Resectable Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC+Immune-targeted therapy | Experimental | Drug: Adebrelimab, Drug: Lenvatinib, Procedure: Hepatic Arterial Infusion ChemotherapyHepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18 to 75 years old, male or female;
- Biliary tract malignant tumors confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan ≥10mm, meeting RECIST 1.1 standards);
- Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma;
- Clinical stage: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma stage: IIIA-IV;
- Expected survival > 3 months;
Key exclusion criteria (11 listed)
- Patients diagnosed with periampullary cancer;
- 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;
- Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
- Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdebrelimabAlso: SHR-1316Adebrelimab, IV | Drug | HAIC+Immune-targeted therapy |
| LenvatinibAlso: Lenvatinib Mesilate CapsulesLenvatinib, PO | Drug | HAIC+Immune-targeted therapy |
| Hepatic Arterial Infusion ChemotherapyGC regimen±5-FU | Procedure or surgery | HAIC+Immune-targeted therapy |
Primary outcome
R0 resection rate
Time frame: up to 24 months
Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.
Surgery conversion rate
Time frame: up to 24 months
Proportion of patients who can undergo surgical resection among all enrolled patients
6 secondary outcomes
Objective response rate
Time frame: up to 24 months
pathological complete response rate
Time frame: up to 24 months
Major pathological response rate
Time frame: up to 24 months
Recurrence-free survival
Time frame: up to 24 months
Overall survival
Time frame: up to 24 months
AEs
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Cancer
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Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yubao Zhang, MD principal investigator
Harbin Medical University Affiliated Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Lenvatinib and Hepatic Arterial Infusion Chemotherapy in people with Biliary Tract Cancer, run by Harbin Medical University.
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 12 inclusion and 11 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yubao Zhang, MD (+86 139 3658 8077, zhyb88077@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2024.