Intrahepatic CholangiocarcinomaPhase 2NCT04834674
DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma
A Phase 2 study testing DEB-TACE combined with apatinib and PD-1 antibody in people with Intrahepatic Cholangiocarcinoma and Transarterial Chemoembolization, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of biliary epithelial cells that originates from the branches of the intrahepatic bile duct at the second level and above. Its incidence accounts for about 15%-20% of primary liver malignancies, showing a gradually increasing trend. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Transarterial Chemoembolization, Apatinib
- What is being tested?
- DEB-TACE combined with apatinib and PD-1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 5 Apr 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of ICC
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- Stand first-line chemotherapy resistance.
- Performance status (PS) ≤ 2 (ECOG scale).
- Child Pugh score ≤ 7.
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
- Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan
Who cannot join
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
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- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known central nervous system tumors including metastatic brain disease
- Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
- Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration.
- Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
About this study
Official title: Drug-eluting Beads Transarterial Chemoembolization Combined With Apatinib and PD-1 Antibody for the Treatment of Intrahepatic Cholangiocarcinoma That Has Progressed After Standard First-line Chemotherapy
Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of biliary epithelial cells that originates from the branches of the intrahepatic bile duct at the second level and above. Its incidence accounts for about 15%-20% of primary liver malignancies, showing a gradually increasing trend. Surgical resection is currently the main method for the treatment of ICC. However, most (60% -70%) patients are diagnosed at the advanced stage. Gemcitabine plus cisplatin is the standard first-line incurable resection recommended in international and domestic guidelines. There is not a standard second-line treatment that has progressed after standard first-line chemotherapy.
The clinical benefits of immune therapies for HCC are emerging. Early clinical data already show the safety of immune checkpoint inhibition. This study is to analyze the safety and efficacy of drug-eluting beads transarterial chemoembolization combined with apatinib and carrelizumab injection in the treatment of ICC that has progressed after standard first-line chemotherapy.
Patients who were aged 18 to 80 years with a histological or cytological diagnosis of ICC，locally advanced or multiple liver metastases, including progression after gemcitabine chemotherapy, will be enrolled in this trial.
Read the detailed description
This study is a single arm, single center, open label study. It is estimated that 20 patients with intrahepatic cholangiocarcinoma which progressed after treatment with standard first-line chemotherapy in patients will be enrolled. The trial period of subjects includes screening period, treatment period and follow-up period.
The drug treatment was 200 mg of PD-1 monoclonal antibody, intravenous infusion on the first day, every 21 days as a treatment cycle; mesylate apatinib, 250 mg, oral once a day, continuous oral; DEB-TACE, the CalliSpheres + gemcitabine (800mg) and oxaliplatin were injected into the hepatic artery by routine procedure, repeated every 4-6 weeks, and administered for according to the physician in charge, DEB-TACE treatment cycles. Treatment continues until the disease progresses, intolerable toxicity occurs, new anti-tumor treatment is started, informed consent is withdrawn, follow-up is lost, death occurs or treatment termination is required。 Screening will be performed between days - 21 and - 4. Informed consent was signed up to 4 weeks prior to the first day of cycle 1 before any screening procedure or evaluation was performed and the trial was fully explained to each subject.
Baseline evaluation results must be collected prior to the first trial drug administration (day 1 of cycle 1). Baseline assessments may be performed between days - 3 and - 1 or on day 1 of cycle 1. If performed within 3 days before the first day of cycle 1, the screening results can be used as baseline results.
The tumor imaging was evaluated every 4-6 weeks since the first administration, and every 12 weeks (± 7 days) after 24 weeks. If there are clinical indications for disease progression, tumor evaluation is more frequent. In the event of disease progression, unacceptable toxicity, the subject's request to discontinue the trial or the subject's withdrawal of consent, the subject will discontinue the trial treatment.
When the trial treatment is stopped, the treatment visit shall be stopped within 7 days after the treatment is stopped in order to stop the treatment examination.
After the end of the treatment period (up to 2 years), subjects who can benefit from the study drug will continue to study the treatment of the drug until disease progression, intolerable adverse reactions, withdrawal of intensive care facility (ICF), other anti-tumor treatment, loss of follow-up, death or termination of the study.
After the occurrence of a clinical event, if it is judged by the investigators that it should be attributed to the progress of the disease and it is unlikely to recover even if the patient continues to receive treatment, it can be evaluated as clinical deterioration. It is up to the investigator to discuss and decide whether to continue or stop the treatment for the subject and record in the study file.
At the end of the study, subjects who are still under study treatment can continue to receive treatment through another extended study or other forms at the discretion of the investigator if they are stable or relieved in the efficacy evaluation and can tolerate the adverse reactions.
- Being tested
- DEB-TACE combined with apatinib and PD-1 antibody
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACE combined with apatinib and PD-1 antibodyCombination product
combination of local therapy (DEB-TACE), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE combined with apatinib and PD-1 antibody | Experimental | The participants will receive the combined treatment of local therapy (DEB-TACE, oxaliplatin and gemcitabine), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody) Receives: Combination Product: DEB-TACE combined with apatinib and PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR = CR + PR
Measured: Change from baseline tumor volume at 6 months
progression free survival (PFS)
Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.
Measured: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
overall survival (OS)
the time from the beginning of treatment to death caused by any reason (the last follow-up time is for the patients who lost the visit; the end of the study is for the patients who are still alive)
Measured: 1 year
disease control rate (DCR)
It is the sum of the proportion of complete response (CR), partial response(PR) and stable disease(SD). That is, DCR = CR + PR + SD
Measured: 6 months
time to progression (TTP)
Time from the beginning of treatment to the objective progression of tumor
Measured: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed 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 posted8 Apr 2021
- Study start1 Jul 2024
- Primary completion5 Apr 2026
- Study completion5 Apr 2026
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
- Model description
- Intervention：Drug-eluting beads transarterial chemoembolization with CalliSpheres microspheres Drug: Apatinib 250mg once daily (QD) oral dosing. Drug: PD-1 antibody 200mg every 3 weeks Other Name: Programmed cell death 1 antibody
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohui Xu, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834674
- Sponsor's protocol ID
- GHX
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2021
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-eluting Beads Transarterial Chemoembolization Combined With Apatinib and PD-1 Antibody for the Treatment of Intrahepatic Cholangiocarcinoma That Has Progressed After Standard First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT04834674
- Acronym / sponsor ID
- GHX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 8 Apr 2021 (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.
Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of biliary epithelial cells that originates from the branches of the intrahepatic bile duct at the second level and above. Its incidence accounts for about 15%-20% of primary liver malignancies, showing a gradually increasing trend. Surgical resection is currently the main method for the treatment of ICC. However, most (60% -70%) patients are diagnosed at the advanced stage. Gemcitabine plus cisplatin is the standard first-line incurable resection recommended in international and domestic guidelines. There is not a standard second-line treatment that has progressed after standard first-line chemotherapy.
The clinical benefits of immune therapies for HCC are emerging. Early clinical data already show the safety of immune checkpoint inhibition. This study is to analyze the safety and efficacy of drug-eluting beads transarterial chemoembolization combined with apatinib and carrelizumab injection in the treatment of ICC that has progressed after standard first-line chemotherapy.
Patients who were aged 18 to 80 years with a histological or cytological diagnosis of ICC，locally advanced or multiple liver metastases, including progression after gemcitabine chemotherapy, will be enrolled in this trial.
Detailed description
This study is a single arm, single center, open label study. It is estimated that 20 patients with intrahepatic cholangiocarcinoma which progressed after treatment with standard first-line chemotherapy in patients will be enrolled. The trial period of subjects includes screening period, treatment period and follow-up period.
The drug treatment was 200 mg of PD-1 monoclonal antibody, intravenous infusion on the first day, every 21 days as a treatment cycle; mesylate apatinib, 250 mg, oral once a day, continuous oral; DEB-TACE, the CalliSpheres + gemcitabine (800mg) and oxaliplatin were injected into the hepatic artery by routine procedure, repeated every 4-6 weeks, and administered for according to the physician in charge, DEB-TACE treatment cycles. Treatment continues until the disease progresses, intolerable toxicity occurs, new anti-tumor treatment is started, informed consent is withdrawn, follow-up is lost, death occurs or treatment termination is required。 Screening will be performed between days - 21 and - 4. Informed consent was signed up to 4 weeks prior to the first day of cycle 1 before any screening procedure or evaluation was performed and the trial was fully explained to each subject.
Baseline evaluation results must be collected prior to the first trial drug administration (day 1 of cycle 1). Baseline assessments may be performed between days - 3 and - 1 or on day 1 of cycle 1. If performed within 3 days before the first day of cycle 1, the screening results can be used as baseline results.
The tumor imaging was evaluated every 4-6 weeks since the first administration, and every 12 weeks (± 7 days) after 24 weeks. If there are clinical indications for disease progression, tumor evaluation is more frequent. In the event of disease progression, unacceptable toxicity, the subject's request to discontinue the trial or the subject's withdrawal of consent, the subject will discontinue the trial treatment.
When the trial treatment is stopped, the treatment visit shall be stopped within 7 days after the treatment is stopped in order to stop the treatment examination.
After the end of the treatment period (up to 2 years), subjects who can benefit from the study drug will continue to study the treatment of the drug until disease progression, intolerable adverse reactions, withdrawal of intensive care facility (ICF), other anti-tumor treatment, loss of follow-up, death or termination of the study.
After the occurrence of a clinical event, if it is judged by the investigators that it should be attributed to the progress of the disease and it is unlikely to recover even if the patient continues to receive treatment, it can be evaluated as clinical deterioration. It is up to the investigator to discuss and decide whether to continue or stop the treatment for the subject and record in the study file.
At the end of the study, subjects who are still under study treatment can continue to receive treatment through another extended study or other forms at the discretion of the investigator if they are stable or relieved in the efficacy evaluation and can tolerate the adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention：Drug-eluting beads transarterial chemoembolization with CalliSpheres microspheres Drug: Apatinib 250mg once daily (QD) oral dosing. Drug: PD-1 antibody 200mg every 3 weeks Other Name: Programmed cell death 1 antibody
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE combined with apatinib and PD-1 antibody | Experimental | Combination Product: DEB-TACE combined with apatinib and PD-1 antibodyThe participants will receive the combined treatment of local therapy (DEB-TACE, oxaliplatin and gemcitabine), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The diagnosis of ICC
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- Stand first-line chemotherapy resistance.
- Performance status (PS) ≤ 2 (ECOG scale).
- Child Pugh score ≤ 7.
Key exclusion criteria (11 listed)
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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 |
|---|---|---|
| DEB-TACE combined with apatinib and PD-1 antibodycombination of local therapy (DEB-TACE), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody) | Combination product | DEB-TACE combined with apatinib and PD-1 antibody |
Primary outcome
objective response rate (ORR)
Time frame: Change from baseline tumor volume at 6 months
The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR = CR + PR
progression free survival (PFS)
Time frame: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.
3 secondary outcomes
overall survival (OS)
Time frame: 1 year
disease control rate (DCR)
Time frame: 6 months
time to progression (TTP)
Time frame: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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 DEB-TACE combined with apatinib and PD-1 antibody in people with Intrahepatic Cholangiocarcinoma and Transarterial Chemoembolization, run by Sichuan Cancer Hospital and Research Institute 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 8 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: finished, as of the sponsor's last update on 7 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (ORR) (time frame: Change from baseline tumor volume at 6 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 7 Apr 2026.