Biliary Tract AdenocarcinomaPhase 2NCT05350943
HAIC Combined With Toripalimab and Donafenib for Advanced BTC
A Phase 2 study testing HAIC, Gemcitabine and Oxaliplatin in people with Biliary Tract Adenocarcinoma, run by Lu Wang, MD, PhD at 1 site in China.
Trial summary
This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Adenocarcinoma
- What is being tested?
- HAIC, Gemcitabine and Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age, of any sex;
- Histologically/Cytologically confirmed diagnosis of unresectable advanced adenocarcinoma of the gallbladder, intrahepatic bile duct and extrahepatic bile duct.
- At least one measurable lesion umder CT/MRI as defined by RECIST1.1 criteria
- Patients must have adequate organ and marrow function as defined below:
- Blood test:
- Hemoglobin (HB) ≥90 g/L Absolute neutrophil count (ANC) ≥1.5×10^9/L； Platelet (PLT) ≥80×10^9/L；
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- Biochemical test:
- total bilirubin≤2×ULN (institutional upper limit of norm) AST(SGOT)/ALT(SGPT)≤2.5 ×ULN creatinine clearance≥ 50 ml/min as calculated by the Cockroft-Gault formula
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
- Indocyanine Green Retention Rates at 15 min (ICGR15<22%;
- Life expectancy of > 3 months;
Who cannot join
- Patients with other malignant tumors should be excluded
- Female patients who are pregnant or breast-feeding. Female patients who are pregnant during the study should also exit.
- Patient has enter any other clinical trails within 4 weeks prior to study entry.
- Patient known with a severe and/or uncontrolled medical disease.
- Chronic non-healing wound/bone fracture
- History of organ transplant
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- Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), those have bleeding tendency (14 days prior to randomization must meet: INR is within the normal range without any use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogous therapy; use for preventive purposes is permitted provided that the international normalized ratio of prothrombin time (INR) ≤ 1.5, take low-dose warfarin (1 mg PO, QD) or low-dose aspirin (do not exceed 100 mg per day);
- Previous history of aterial/venous thrombosis such as cerebrovascular accidents, pulmonary embolism or deep venous thrombosis within one year prior to patients recruitment.
- Hitstory of psychiatric drug abuse and hasn't come clean, or with psychiatric illness/social situations that would limit compliance with study requirements
- History of immunodeficiency, or other acquired/congenital immunodeficiency diseases
- Concomitant diseases that severely endanger the safety of the subject or affect the study completion according to the judgment of the investigator
- Willingness to sign a written informed consent document, with good compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Evaluate the Efficacy and Safety of HAIC Combined With Toripalimab and Donafenib in Patients With Advanced Biliary Tract Cancer
This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer.
- Conditions
- Biliary Tract Adenocarcinoma
- Being tested
- HAIC, Gemcitabine, Oxaliplatin, Toripalimab, Donafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAICProcedure or surgery
After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs.
GemcitabineDrug
1000 mg/m^2 in 100ml saline solution IV, d1, Q3W
OxaliplatinDrug
85 mg/m^2 in 500ml 5% glucose solution over 2 hours IV, d1, Q3W
ToripalimabDrug
3mg/kg (body weight < 60kg) or 240 mg（body weight>= 60kg）in 250 saline soluation, IV, Q3W
DonafenibDrug
0.2mg. P.O, BID, continuously
| Study group | Role | What they receive |
|---|---|---|
| HAIC+Toripalimab+Donafenib | Experimental | HAIC(GEMOX)+Toripalimab+Donafenib Receives: Procedure: HAIC; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Toripalimab; Drug: Donafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
the sum of complete response rate and partial response rate
Measured: through study completion, an average of 2 year
Secondary outcomes (5)
Disease Control rate (DCR)
the sum of complete response rate, partial response rate and stable disease rate
Measured: through study completion, an average of 2 year
Progression-free survival (PFS)
Time from randomization to disease progression
Measured: through study completion, an average of 2 year
Overall survival (OS)
Time from randomization to death for any cause
Measured: through study completion, an average of 2 year
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0.
Unforeseen medical events occurred when the subjects received drug treatment or research, but there is not necessarily a causal relationship with the drugs used.
Severe adverse events
Measured: through study completion, an average of 2 year
Quality of life questionnaire
The concept of comprehensively evaluating the quality of life
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Mar 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract AdenocarcinomaStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Wang, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350943
- Sponsor's protocol ID
- 2021-GZWK-04
- Status last verified
- Oct 2022
- First submitted
- 24 Mar 2022
- Last updated
- 18 Oct 2022
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy and Safety of HAIC Combined With Toripalimab and Donafenib in Patients With Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT05350943
- Acronym / sponsor ID
- 2021-GZWK-04
- Conditions
- Biliary Tract Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lu Wang, MD, PhDUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 28 Apr 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.
This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC+Toripalimab+Donafenib | Experimental | Procedure: HAIC, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Toripalimab, Drug: DonafenibHAIC(GEMOX)+Toripalimab+Donafenib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 80 years of age, of any sex;
- Histologically/Cytologically confirmed diagnosis of unresectable advanced adenocarcinoma of the gallbladder, intrahepatic bile duct and extrahepatic bile duct.
- At least one measurable lesion umder CT/MRI as defined by RECIST1.1 criteria
- Patients must have adequate organ and marrow function as defined below:
- Hemoglobin (HB) ≥90 g/L Absolute neutrophil count (ANC) ≥1.5×10^9/L； Platelet (PLT) ≥80×10^9/L；
Key exclusion criteria (12 listed)
- Patients with other malignant tumors should be excluded
- Female patients who are pregnant or breast-feeding. Female patients who are pregnant during the study should also exit.
- Patient has enter any other clinical trails within 4 weeks prior to study entry.
- Patient known with a severe and/or uncontrolled medical disease.
- Chronic non-healing wound/bone fracture
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 |
|---|---|---|
| HAICAfter successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs. | Procedure or surgery | HAIC+Toripalimab+Donafenib |
| Gemcitabine1000 mg/m^2 in 100ml saline solution IV, d1, Q3W | Drug | HAIC+Toripalimab+Donafenib |
| Oxaliplatin85 mg/m^2 in 500ml 5% glucose solution over 2 hours IV, d1, Q3W | Drug | HAIC+Toripalimab+Donafenib |
| Toripalimab3mg/kg (body weight < 60kg) or 240 mg（body weight>= 60kg）in 250 saline soluation, IV, Q3W | Drug | HAIC+Toripalimab+Donafenib |
| Donafenib0.2mg. P.O, BID, continuously | Drug | HAIC+Toripalimab+Donafenib |
Primary outcome
Objective response rate (ORR)
Time frame: through study completion, an average of 2 year
the sum of complete response rate and partial response rate
5 secondary outcomes
Disease Control rate (DCR)
Time frame: through study completion, an average of 2 year
Progression-free survival (PFS)
Time frame: through study completion, an average of 2 year
Overall survival (OS)
Time frame: through study completion, an average of 2 year
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0.
Time frame: through study completion, an average of 2 year
Quality of life questionnaire
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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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 HAIC, Gemcitabine and Oxaliplatin in people with Biliary Tract Adenocarcinoma, run by Lu Wang, MD, PhD 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 11 inclusion and 12 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 18 Oct 2022. 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 (ORR) (time frame: through study completion, an average of 2 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 18 Oct 2022.