Intrahepatic CholangiocarcinomaPhase 2NCT06296563
Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC
A Phase 2 study testing HAIC, Adebrelimab and Apatinib in people with Intrahepatic Cholangiocarcinoma, run by Lei ZHAO at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. 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?
- HAIC, Adebrelimab and Apatinib
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Mar 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
- 2. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectable subjects were classified as Ib-IIIb stages;
- 3. aged ≥ 18 years at the time of signing the Informed consent form (ICF);
- 4. Expected survival time>3 months;
- 5. Both men and women are eligible;
- 6. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or 1;
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- 7. No serious complications, such as hypertension, coronary heart disease, or history of mental illness, and no history of severe allergies; Non pregnancy and non lactation period;
- 8. The organ and blood system functions of the subjects meet the following requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9/L;
- Platelet count ≥ 75 × 10 ^ 9/L;
- Hemoglobin ≥ 90 g/L;
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN;
- Albumin ≥ 3g/dL
- Creatinine ≤ 1.5 x ULN
- 9. The subjects can understand and sign the informed consent form to participate in the experimental study; Good compliance.
- 10. Participants who have not undergone any local or systemic treatment for tumors in the past, and have undergone radical resection surgery for biliary tract cancer before recurrence for at least 2 years, can be included;
- 11. Subjects with potential fertility need to use a medically approved contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within one month after the end of the study treatment period; And within 72 hours before enrollment, the serum or urine HCG test must be negative and must be non lactating;
Who cannot join
- 1. Patients who received PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors before enrollment, or patients who directly received another stimulating or co inhibitory T cell receptor (such as CTLA-4, CD137);
- 2. Use any other investigational drugs within 4 weeks prior to enrollment;
- 3. Any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); Children with asthma who have completely improved in adulthood and do not require any intervention can be included, but patients who require intervention with bronchodilators cannot be included;
- 4. Congenital or acquired immunodeficiency, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody positive, HCV-RNA above the detection limit of the analysis method), or co infection with hepatitis B and hepatitis C;
- 5. Serious infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or unexplained fever>38.5 ° C occurred during screening/before the first administration;
- 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
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- 7. Suffering from uncontrollable mental illness;
- 8. The simultaneous occurrence of serious and/or uncontrollable diseases may affect the participation of the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, serious activities, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct);
- 9. Pregnancy (positive pregnancy test) or lactation period;
- 10. Other cancers that have occurred in the past (within the past 5 years) or simultaneously, excluding non melanoma skin cancer and in situ cancer;
- 11. History of allergy or hypersensitivity to any investigational drug;
- 12. Currently abusing alcohol or illegal drugs;
- 13. Unable or unwilling to sign informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Lei Zhao, MD, +86 053167626368, drzhaolei@hotmail.com
Peifei Sun, MD, +86 053167626242
About this study
Official title: A Single Arm, Exploratory Clinical Study on the Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC
The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:
How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.
Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- HAIC, Adebrelimab, Apatinib
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAICProcedure or surgery
FOLFOX-hepatic artery infusion for 2 times.
AdebrelimabDrug
Adebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most.
ApatinibDrug
Apatinib 250mg, po, qd,q3w,up to one year of use at most.
| Study group | Role | What they receive |
|---|---|---|
| HAIC+Adebrelimab+apatinib | Experimental | Neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib. Receives: Procedure: HAIC; Drug: Adebrelimab; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
The proportion of subjects whose postoperative pathological examination did not detect residual cancer cells.
Measured: Up to one year
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate
Measured: Up to one year
Event free survival (EFS)
The time from enrollment to the scheduled occurrence of events, including death, disease recurrence, disease progression, etc
Measured: Up to two years
Overall Survival (OS)
Overall Survival：The survival time from enrollment to death from any cause.
Measured: Up to two years
Disease Control Rate (DCR)
Disease Control Rate: Ratio of complete response (CR)+partial response (PR)+stable disease (SD)
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2029 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei ZHAO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei ZHAO, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296563
- Sponsor's protocol ID
- SHR1316-ICC-SD-001
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 17 Apr 2024
- Results posted
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Exploratory Clinical Study on the Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC
- ClinicalTrials.gov ID
- NCT06296563
- Acronym / sponsor ID
- SHR1316-ICC-SD-001
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lei ZHAOUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 6 Mar 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.
The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:
How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.
Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC+Adebrelimab+apatinib | Experimental | Procedure: HAIC, Drug: Adebrelimab, Drug: ApatinibNeoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
- 2. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectable subjects were classified as Ib-IIIb stages;
- 3. aged ≥ 18 years at the time of signing the Informed consent form (ICF);
- 4. Expected survival time>3 months;
- 5. Both men and women are eligible;
Key exclusion criteria (13 listed)
- 1. Patients who received PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors before enrollment, or patients who directly received another stimulating or co inhibitory T cell receptor (such as CTLA-4, CD137);
- 2. Use any other investigational drugs within 4 weeks prior to enrollment;
- 3. Any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); Children with asthma who have completely improved in adulthood and do not require any intervention can be included, but patients who require intervention with bronchodilators cannot be included;
- 4. Congenital or acquired immunodeficiency, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody positive, HCV-RNA above the detection limit of the analysis method), or co infection with hepatitis B and hepatitis C;
- 5. Serious infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or unexplained fever>38.5 ° C occurred during screening/before the first administration;
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 |
|---|---|---|
| HAICFOLFOX-hepatic artery infusion for 2 times. | Procedure or surgery | HAIC+Adebrelimab+apatinib |
| AdebrelimabAdebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most. | Drug | HAIC+Adebrelimab+apatinib |
| ApatinibApatinib 250mg, po, qd,q3w,up to one year of use at most. | Drug | HAIC+Adebrelimab+apatinib |
Primary outcome
Pathologic complete response (pCR)
Time frame: Up to one year
The proportion of subjects whose postoperative pathological examination did not detect residual cancer cells.
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to one year
Event free survival (EFS)
Time frame: Up to two years
Overall Survival (OS)
Time frame: Up to two years
Disease Control Rate (DCR)
Time frame: Up to one year
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 17 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.
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 HAIC, Adebrelimab and Apatinib in people with Intrahepatic Cholangiocarcinoma, run by Lei ZHAO 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 18 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 17 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) (time frame: Up to one year). 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 17 Apr 2024.