Intrahepatic CholangiocarcinomaPhase 2NCT06375642
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 study testing Adebrelimab in people with Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Adebrelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form before enrollment;
- Age > 18 years, both men and women;
- Patients with histologically or pathologically confirmed intrahepatic cholangiocarcinoma;
- No previous systemic therapy and local therapy;
- 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);
- ECOG PS score: 0-1;
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- Expected survival greater than 12 weeks;
- 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
- International normalized ratio INR ≤ 1.5 × ULN;
- Partial thromboplastin time APTT ≤ 1.5 × ULN;
- 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.
- 11. The subject voluntarily joins this study, has good compliance, and cooperates with safety and survival follow-up
Who cannot join
- The subject has previous or concurrent other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
- 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;
- 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);
- 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;
- Ascites or pleural effusion with clinical symptoms, ascites requiring therapeutic puncture or regular drainage (≥ 1 time/month);
- 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;
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- 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);
- Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function;
- Subjects with congenital or acquired immunodeficiency, such as HIV infection;
- Live vaccines less than 4 weeks before study drug or likely during the study;
- The subject has a known history of psychiatric drug abuse, alcoholism or drug abuse;
- Patients who cannot be orally administered;
- Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
About this study
Official title: A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based Hepatic Artery Infusion Chemotherapy in the Treatment of Advanced Intrahepatic Cholangiocarcinoma
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.
Read more
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.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Adebrelimab
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called Surufatinib, HAIC
Adebrelimab, Surufatinib and HAIC
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | 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. Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
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
Measured: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Secondary outcomes (5)
Overall Survival
every two months follow up after EOT observation period at 30 days after the last medication
Measured: from treatment initiation until death due to any cause, assessed up to 3 year
Progress-Free Survival
every two months follow up after EOT observation period at 30 days after the last medication
Measured: from treatment initiation until death due to any cause, assessed up to 2 year
Incidence and severity of AE and SAE
Safety
Measured: from first dose to 30 days post the last dose
Dose suspension rate caused by adverse events
Safety
Measured: from first dose to 30 days post the last dose
dose termination rate caused by adverse events
Safety
Measured: from first dose to 30 days post the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start10 May 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HuiKai Li, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375642
- Sponsor's protocol ID
- SHR1316-HMPL012-HAIC-01
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 19 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based Hepatic Artery Infusion Chemotherapy in the Treatment of Advanced Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06375642
- Acronym / sponsor ID
- SHR1316-HMPL012-HAIC-01
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: AdebrelimabSurufatinib: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign a written informed consent form before enrollment;
- Age > 18 years, both men and women;
- Patients with histologically or pathologically confirmed intrahepatic cholangiocarcinoma;
- No previous systemic therapy and local therapy;
- 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);
Key exclusion criteria (14 listed)
- The subject has previous or concurrent other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
- 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;
- 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);
- 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;
- Ascites or pleural effusion with clinical symptoms, ascites requiring therapeutic puncture or regular drainage (≥ 1 time/month);
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: Surufatinib, HAICAdebrelimab, Surufatinib and HAIC | Drug | Study arm |
Primary outcome
Objective Response Rate
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease(PD), using RECIST v1.1
Disease Control Rate
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease(PD), using RECIST v1.1
5 secondary outcomes
Overall Survival
Time frame: from treatment initiation until death due to any cause, assessed up to 3 year
Progress-Free Survival
Time frame: from treatment initiation until death due to any cause, assessed up to 2 year
Incidence and severity of AE and SAE
Time frame: from first dose to 30 days post the last dose
Dose suspension rate caused by adverse events
Time frame: from first dose to 30 days post the last dose
dose termination rate caused by adverse events
Time frame: from first dose to 30 days post the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab in people with Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 13 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year). 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 19 Apr 2024.