Intrahepatic CholangiocarcinomaPhase 2NCT05400902
HAIC Combined With Sintilimab and Bevacizumab for Unresectable Intrahepatic Cholangiocarcinoma
A Phase 2 study testing HAIC Combined with Tislelizumab and Apatinib in people with Intrahepatic Cholangiocarcinoma, run by Binkui Li at 1 site in China.
Trial summary
Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- HAIC Combined with Tislelizumab and Apatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 31 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICC diagnosed by imaging examination (CT or MRI) and pathology;
- ICC patient without any previous tumor treatment
- The tumor was assessed as unresectable by two liver surgeons. Any of the following conditions: (1) Residual liver volume less than 30-40%; (2) Not possible for R0 radical resection; (3) Tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein.
- At least one assessable intrahepatic lesion;
- ECOG PS score 0-1;
- Child-Pugh class A;
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- Life expectancy is at least 3 months;
- Age between 18 and 75 years old;
- Baseline laboratory tests meet the following criteria:
- Neutrophils ≥1.5×10^9/L White blood cells ≥3.0×10^9/L Platelets ≥75×10^9/L Hemoglobin ≥80g/L Serum ALT, AST ≤ 3 x upper limit of normal (ULN) Serum creatinine ≤ 1.5 x ULN INR < 1.5, or prothrombin time < ULN+4 seconds Albumin ≥30g/L Total bilirubin ≤ 3 x upper limit of normal (ULN)
Who cannot join
- Distant metastasis;
- Refused to receive PD-1 inhibitor and apatinib treatment;
- Any of the following conditions within the first 12 months of the study: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), Pulmonary embolism; ongoing: arrhythmia grade ≥2 according to NCI-CTCAE criteria, QTc prolongation (>450 ms in men, >470 ms in women);
- Renal insufficiency requires peritoneal dialysis or hemodialysis;
- Serious dysfunction of other important organs;
- A second primary malignant tumor was diagnosed in the past;
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- Known or new evidence of brain or leptomeningeal lesions;
- Hemophilia or bleeding tendency, who are taking anticoagulation therapy such as coumarin derivatives in therapeutic doses;
- Pregnant or lactating women, all female patients of childbearing potential must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative;
- History of previous organ transplantation;
- Known HIV infection;
- Allergy to chemotherapy drugs;
- Patients with other serious acute or chronic physical or psychiatric diseases or abnormal laboratory tests that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results or the investigators consider unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Wei He, 15521248313, hewei@sysucc.org.cn
Binkui Li
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Bevacizumab in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: A Prospective, Single-Center, Phase II Study
Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with sintilimab and bevacizumabin the treatment of unresectable ICC.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- HAIC Combined with Tislelizumab and Apatinib
- Keywords
- Intrahepatic Cholangiocarcinoma, Hepatic Arterial Infusion Chemotherapy, Sintilimab, Bevacizumab
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC Combined with Tislelizumab and ApatinibDrug
Hepatic Arterial Infusion Chemotherapy: FOLFOX6 regimen was infused with chemotherapy drugs: oxaliplatin 130 mg/m2 infusion for 2 hours, folinate calcium 400 mg/m2 infusion for 2 hours, 5-fluorouracil 400 mg/m2 arterial infusion for 10 minutes, 5-fluorouracil 1200 mg/m2 infusion for 23 hours. Every 3 weeks, no more than 4 cycles of HAIC treatment.
Sintilimab and Bevacizumab treatment: start at 0-3 days after the end of hepatic arterial infusion chemotherapy: Sintilimab 200 mg ivdrip, Q3W; Bevacizumab 15 mg/kg ivdrip, Q3W
| Study group | Role | What they receive |
|---|---|---|
| HAIC Combined with Sintilimab and Bevacizumab | Experimental | Not described Receives: Drug: HAIC Combined with Tislelizumab and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
The objective response rate was calculated according to the RECIST 1.1.
Measured: 12 months
Secondary outcomes (4)
Progression-free survival
defined as the time from the start of enrollment to the time of tumor progression (PD) or death or last follow-up on imaging.
Measured: 12 months
Disease Control Rate
According to the RECIST 1.1 standard, complete remission + partial remission + disease control rate were calculated.
Measured: 12 months
Conversion rate to resection
Defined as the rate of surgical resection among all enrolled patients.
Measured: 12 months
Overall Survival time
Defined as the time from enrollment until death from any cause.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start31 May 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binkui Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Binkui Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400902
- Sponsor's protocol ID
- B2022-233-01
- Status last verified
- Apr 2023
- First submitted
- 28 May 2022
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Bevacizumab in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: A Prospective, Single-Center, Phase II Study
- ClinicalTrials.gov ID
- NCT05400902
- Acronym / sponsor ID
- B2022-233-01
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Intrahepatic Cholangiocarcinoma, Hepatic Arterial Infusion Chemotherapy, Sintilimab, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Binkui LiUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with sintilimab and bevacizumabin the treatment of unresectable ICC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC Combined with Sintilimab and Bevacizumab | Experimental | Drug: HAIC Combined with Tislelizumab and Apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ICC diagnosed by imaging examination (CT or MRI) and pathology;
- ICC patient without any previous tumor treatment
- The tumor was assessed as unresectable by two liver surgeons. Any of the following conditions: (1) Residual liver volume less than 30-40%; (2) Not possible for R0 radical resection; (3) Tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein.
- At least one assessable intrahepatic lesion;
- ECOG PS score 0-1;
Key exclusion criteria (13 listed)
- Distant metastasis;
- Refused to receive PD-1 inhibitor and apatinib treatment;
- Any of the following conditions within the first 12 months of the study: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), Pulmonary embolism; ongoing: arrhythmia grade ≥2 according to NCI-CTCAE criteria, QTc prolongation (>450 ms in men, >470 ms in women);
- Renal insufficiency requires peritoneal dialysis or hemodialysis;
- Serious dysfunction of other important organs;
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 |
|---|---|---|
| HAIC Combined with Tislelizumab and ApatinibHepatic Arterial Infusion Chemotherapy: FOLFOX6 regimen was infused with chemotherapy drugs: oxaliplatin 130 mg/m2 infusion for 2 hours, folinate calcium 400 mg/m2 infusion for 2 hours, 5-fluorouracil 400 mg/m2 arterial infusion for 10 minutes, 5-fluorouracil 1200 mg/m2 infusion for 23 hours. Every 3 weeks, no more than 4 cycles of HAIC treatment. Sintilimab and Bevacizumab treatment: start at 0-3 days after the end of hepatic arterial infusion chemotherapy: Sintilimab 200 mg ivdrip, Q3W; Bevacizumab 15 mg/kg ivdrip, Q3W | Drug | HAIC Combined with Sintilimab and Bevacizumab |
Primary outcome
Response Rate
Time frame: 12 months
The objective response rate was calculated according to the RECIST 1.1.
4 secondary outcomes
Progression-free survival
Time frame: 12 months
Disease Control Rate
Time frame: 12 months
Conversion rate to resection
Time frame: 12 months
Overall Survival time
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- 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.
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 Combined with Tislelizumab and Apatinib in people with Intrahepatic Cholangiocarcinoma, run by Binkui Li 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 10 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. 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?
Contact Binkui Li (+862087343951, libk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 12 months). 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 13 Apr 2023.