CholangiocarcinomaNCT05697237
Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
A study testing Carrelizumab and Solfantinib in people with Cholangiocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The incidence of cholangiocarcinoma is high, the radical resection rate is low, the postoperative recurrence is easy, the prognosis is poor.Gemcitabine combined with cisplatin (GC) is the standard first-line treatment for patients with advanced biliary carcinoma, and up to now there is no standard second-line… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Carrelizumab and Solfantinib
- 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
- Jan 2023to Dec 2024
- 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
- Advanced inability to root was pathologically confirmed Patients with curatively resected or metastatic bile duct epithelial cell carcinoma;
- had previously received systemic antitumor therapy with a chemotherapy regimen (including gemcitabine)
- Age ≥18 and under 75
- 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 allergies to carrilizumab or solfantinib machine components
- Patients with obstructive jaundice who could not reach the upper limit of TBIL≤2.5 times of normal value 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, cervical cancer in situ)
- 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 take appropriate contraceptive measures during the course of the 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: Exploratory Clinical Study of Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
The incidence of cholangiocarcinoma is high, the radical resection rate is low, the postoperative recurrence is easy, the prognosis is poor.Gemcitabine combined with cisplatin (GC) is the standard first-line treatment for patients with advanced biliary carcinoma, and up to now there is no standard second-line treatment Commend.Carrilizumab was highly effective in previous studies,Its combined GEMOX protocol has been published in the "Guidelines for the Diagnosis and Treatment of Gallbladder Cancer (2019 Edition)" and the "China Clinical Oncology" The Society's (CSCO) Guidelines for the Diagnosis and Treatment of Biliary alignancies 2020 is recommended for the first-line treatment of advanced biliary cancers.Solfantinib is targeted at VEGFR1, 2, 3, FGFR1And CSF1R highly selective small molecule targeted therapy drugs. Data from a preliminary phase 2 clinical trial observed sofantinib therapy Survival benefits of cholangiocarcinoma patients in China.
Read the detailed description
In this study, carrilizumab combined with suvantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials. The study plan enlists 60 patients with unresectable or recurrent disease confirmed by histopathology or cytology Or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, distal cholangiocarcinoma). Past acceptance of standard containing Systematic internal medicine anti-tumor therapy with gemcitabine regimen met the inclusion criteria of this study, and carrilizumab combined with cord was given Vantinib oral therapy. The specific treatment regimen was carrilizumab 200mg Q3W d1; Solventinib: 300mg, Orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to the treatment regimen The efficacy was evaluated every 2 cycles. The main evaluation of carrilizumab combined with suvantinib in second-line treatment was advanced or Progression-free survival (PFS) in patients with metastatic cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma
- Being tested
- Carrelizumab, Solfantinib
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarrelizumabDrug
Carrelizumab 200mg/3 weeks
SolfantinibDrug
Solfantinib 300mg/d
| Study group | Role | What they receive |
|---|---|---|
| Advanced or metastatic cholangiocarcinoma | Experimental | In this study, carrilizumab combined with sovantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials.The specific treatment regimen was carrilizumab 200mg Q3W d1; Sofantinib: 300mg,Take orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to treatment regimens.The efficacy was evaluated every 2 cycles. Receives: Drug: Carrelizumab; Drug: Solfantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: 6months
Secondary outcomes (3)
ORR
Objective Response Rate
Measured: 6months
OS
Overall Survival
Measured: 12months
DCR
Disease control rate Disease control rate Disease control rate
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (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.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 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
- NCT05697237
- Sponsor's protocol ID
- XJTU1AF2021LSK-368
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 25 Jan 2023
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05697237
- Acronym / sponsor ID
- XJTU1AF2021LSK-368
- 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
- Jan 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jan 2023 (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 incidence of cholangiocarcinoma is high, the radical resection rate is low, the postoperative recurrence is easy, the prognosis is poor.Gemcitabine combined with cisplatin (GC) is the standard first-line treatment for patients with advanced biliary carcinoma, and up to now there is no standard second-line treatment Commend.Carrilizumab was highly effective in previous studies,Its combined GEMOX protocol has been published in the "Guidelines for the Diagnosis and Treatment of Gallbladder Cancer (2019 Edition)" and the "China Clinical Oncology" The Society's (CSCO) Guidelines for the Diagnosis and Treatment of Biliary alignancies 2020 is recommended for the first-line treatment of advanced biliary cancers.Solfantinib is targeted at VEGFR1, 2, 3, FGFR1And CSF1R highly selective small molecule targeted therapy drugs. Data from a preliminary phase 2 clinical trial observed sofantinib therapy Survival benefits of cholangiocarcinoma patients in China.
Detailed description
In this study, carrilizumab combined with suvantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials. The study plan enlists 60 patients with unresectable or recurrent disease confirmed by histopathology or cytology Or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, distal cholangiocarcinoma). Past acceptance of standard containing Systematic internal medicine anti-tumor therapy with gemcitabine regimen met the inclusion criteria of this study, and carrilizumab combined with cord was given Vantinib oral therapy. The specific treatment regimen was carrilizumab 200mg Q3W d1; Solventinib: 300mg, Orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to the treatment regimen The efficacy was evaluated every 2 cycles. The main evaluation of carrilizumab combined with suvantinib in second-line treatment was advanced or Progression-free survival (PFS) in patients with metastatic cholangiocarcinoma.
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: Carrelizumab, Drug: SolfantinibIn this study, carrilizumab combined with sovantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials.The specific treatment regimen was carrilizumab 200mg Q3W d1; Sofantinib: 300mg,Take orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to treatment regimens.The efficacy was evaluated every 2 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced inability to root was pathologically confirmed Patients with curatively resected or metastatic bile duct epithelial cell carcinoma;
- had previously received systemic antitumor therapy with a chemotherapy regimen (including gemcitabine)
- Age ≥18 and under 75
- Predicted survival ≥3 months
- ECOG score 0-1
Key exclusion criteria (10 listed)
- Known allergies to carrilizumab or solfantinib machine components
- Patients with obstructive jaundice who could not reach the upper limit of TBIL≤2.5 times of normal value 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, cervical cancer in situ)
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 |
|---|---|---|
| CarrelizumabCarrelizumab 200mg/3 weeks | Drug | Advanced or metastatic cholangiocarcinoma |
| SolfantinibSolfantinib 300mg/d | Drug | Advanced or metastatic cholangiocarcinoma |
Primary outcome
PFS
Time frame: 6months
Progression Free Survival
3 secondary outcomes
ORR
Time frame: 6months
OS
Time frame: 12months
DCR
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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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 Carrelizumab and Solfantinib 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 25 Jan 2023. 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, 1159950306@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: 6months). 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 25 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.