CholangiocarcinomaNCT05653817
Advanced or Metastatic Cholangiocarcinoma
A study testing Carrilizumab, Albumin-bound paclitaxel and Apatinib in people with Cholangiocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
This is a single-arm, open, multicenter trial of carralizumab in combination with albumin paclitaxel and apatinib mesylate for the second-line treatment of patients with advanced or metastatic cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Carrilizumab, Albumin-bound paclitaxel and Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2023to 31 Jan 2026
- Phase
- Interventional
- 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
- Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma;
- Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel;
- Age ≥18 years old and under 75 years old;
- Predicted survival ≥3 months;
- ECOG score 0-1;
- Child-Pugh score<8
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- There was at least one measurable tumor lesion with a long diameter ≥10 mm and a short diameter ≥15 mm on spiral CT. For general CT or physical examination, the maximum diameter must be ≥20mm;
- The results of liver and kidney function and blood routine examination within 1 week before enrollment were consistent with the following conditions， ANC≥1.5×10^9/L,PLT≥80×10^9/L,HGB≥80g/L,Cr≤1.5×ULN,TBIL≤2.5×ULN,ALP≤2.5×ULN,AST≤2.5×ULN,ALT≤2.5×ULN
- Patients participate voluntarily and sign informed consent forms
Who cannot join
- Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel;
- Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention;
- Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
- Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency;
- History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix);
- Interstitial pneumonia or pulmonary fibrosis;
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- Uncontrollable pleural effusion or ascites;
- Severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months);
- Pregnant or lactating mothers who refused to use appropriate contraceptive methods during the course of this study;
- The researchers determined that the patients were not suitable for this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Clinical Study of Carralizumab Combined With Albumin Paclitaxel and Apatinib Mesylate in the Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
This is a single-arm, open, multicenter trial of carralizumab in combination with albumin paclitaxel and apatinib mesylate for the second-line treatment of patients with advanced or metastatic cholangiocarcinoma. The study enlists patients with histopathologically or cytologically confirmed unresectable, recurrent, or metastatic cholangiocarcinoma (including intrahepatic, extrahepatic, and distal cholangiocarcinoma). Previously, she had received systematic internal medicine anti-tumor therapy with gemcitabine regimen as standard, which met the inclusion criteria of this study. She was given oral therapy with albumin binding paclitaxel combined with carrilizumab and apatinib mesylate. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen. To evaluate progression-free survival (PFS) in second-line therapy with carrilizumab in combination with albumin paclitaxel and apatinib mesylate in patients with advanced or metastatic cholangiocarcinoma.
Read the detailed description
Cholangiocarcinoma (CCA) is a cancer that easily invades adjacent structures. Vascular endothelial growth factor (VEGF) and VEGF receptor 2 (VEGFR2) are increased in most types of cancer and inhibit tumor progression by blocking VEGF/VEGFR2 [16]. Apatinib is a highly selective VEGFR2 antagonist that inhibits apoptosis and growth of CCA cells. Apatinib is also a derivative of PTK787, and its targets include VEGFR-1, VEGFR-2, PDGFR, c-kit, c-Src, etc. The activity of Apatinib against VEGFR-2 is 137 times that of PTK787, the IC50 is only 1nmol/L, and it can strongly inhibit tumor angiogenesis. At the same time, it can also inhibit the downstream signal transduction mediated by KDR and inhibit tumor growth.
- Conditions
- Cholangiocarcinoma
- Being tested
- Carrilizumab, Albumin-bound paclitaxel, Apatinib
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarrilizumabDrug
Carrilizumab 200mg Q3W d1
Albumin-bound paclitaxelDrug
Albumin-bound paclitaxel 125 mg/m2 d1,8
ApatinibDrug
Apatinib mesylate tablets for treatment: 250mg
| Study group | Role | What they receive |
|---|---|---|
| Advanced or metastatic cholangiocarcinoma | Experimental | A multicenter clinical study of carralizumab combined with albumin paclitaxel and apatinib mesylate in the second-line treatment of advanced or metastatic cholangiocarcinoma.Albumin-bound paclitaxel 125 mg/m2 d1,8; Carrilizumab 200mg Q3W d1; Apatinib mesylate tablet treatment: 250mg orally, once a day, continuous administration. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen. Receives: Drug: Carrilizumab; Drug: Albumin-bound paclitaxel; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: 24month
Secondary outcomes (1)
OS
Overall survival
Measured: 24month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start31 Jan 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- enxiao li, PHD, Principal investigator, First hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653817
- Sponsor's protocol ID
- XJTU1AF2021LSK-062
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 16 Dec 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Carralizumab Combined With Albumin Paclitaxel and Apatinib Mesylate in the Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05653817
- Acronym / sponsor ID
- XJTU1AF2021LSK-062
- Conditions
- Cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 16 Dec 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-arm, open, multicenter trial of carralizumab in combination with albumin paclitaxel and apatinib mesylate for the second-line treatment of patients with advanced or metastatic cholangiocarcinoma. The study enlists patients with histopathologically or cytologically confirmed unresectable, recurrent, or metastatic cholangiocarcinoma (including intrahepatic, extrahepatic, and distal cholangiocarcinoma). Previously, she had received systematic internal medicine anti-tumor therapy with gemcitabine regimen as standard, which met the inclusion criteria of this study. She was given oral therapy with albumin binding paclitaxel combined with carrilizumab and apatinib mesylate. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen. To evaluate progression-free survival (PFS) in second-line therapy with carrilizumab in combination with albumin paclitaxel and apatinib mesylate in patients with advanced or metastatic cholangiocarcinoma.
Detailed description
Cholangiocarcinoma (CCA) is a cancer that easily invades adjacent structures. Vascular endothelial growth factor (VEGF) and VEGF receptor 2 (VEGFR2) are increased in most types of cancer and inhibit tumor progression by blocking VEGF/VEGFR2 [16]. Apatinib is a highly selective VEGFR2 antagonist that inhibits apoptosis and growth of CCA cells. Apatinib is also a derivative of PTK787, and its targets include VEGFR-1, VEGFR-2, PDGFR, c-kit, c-Src, etc. The activity of Apatinib against VEGFR-2 is 137 times that of PTK787, the IC50 is only 1nmol/L, and it can strongly inhibit tumor angiogenesis. At the same time, it can also inhibit the downstream signal transduction mediated by KDR and inhibit tumor growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced or metastatic cholangiocarcinoma | Experimental | Drug: Carrilizumab, Drug: Albumin-bound paclitaxel, Drug: ApatinibA multicenter clinical study of carralizumab combined with albumin paclitaxel and apatinib mesylate in the second-line treatment of advanced or metastatic cholangiocarcinoma.Albumin-bound paclitaxel 125 mg/m2 d1,8; Carrilizumab 200mg Q3W d1; Apatinib mesylate tablet treatment: 250mg orally, once a day, continuous administration. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma;
- Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel;
- Age ≥18 years old and under 75 years old;
- Predicted survival ≥3 months;
- ECOG score 0-1;
Key exclusion criteria (10 listed)
- Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel;
- Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention;
- Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
- Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency;
- History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix);
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 |
|---|---|---|
| CarrilizumabCarrilizumab 200mg Q3W d1 | Drug | Advanced or metastatic cholangiocarcinoma |
| Albumin-bound paclitaxelAlbumin-bound paclitaxel 125 mg/m2 d1,8 | Drug | Advanced or metastatic cholangiocarcinoma |
| ApatinibApatinib mesylate tablets for treatment: 250mg | Drug | Advanced or metastatic cholangiocarcinoma |
Primary outcome
PFS
Time frame: 24month
Progression-free survival
1 secondary outcome
OS
Time frame: 24month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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.
enxiao li, PHD principal investigator
First hospital of Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A study testing Carrilizumab, Albumin-bound paclitaxel and Apatinib in people with Cholangiocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University.
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 9 inclusion and 10 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 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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 yangwei fan, phd (+8615029078171, 1289271841@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 24month). 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 16 Dec 2022.