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Trial Title:
Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
NCT ID:
NCT05697237
Condition:
Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carrelizumab
Description:
Carrelizumab 200mg/3 weeks
Arm group label:
Advanced or metastatic cholangiocarcinoma
Intervention type:
Drug
Intervention name:
Solfantinib
Description:
Solfantinib 300mg/d
Arm group label:
Advanced or metastatic cholangiocarcinoma
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Advanced inability to root was pathologically confirmed Patients with curatively
resected or metastatic bile duct epithelial cell carcinoma;
2. had previously received systemic antitumor therapy with a chemotherapy regimen
(including gemcitabine)
3. Age ≥18 and under 75
4. Predicted survival ≥3 months
5. ECOG score 0-1
6. Child-Pugh score < 8
7. 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
8. 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×UL
N,AST≤2.5×ULN,ALT≤2.5×ULN
9. Patients participate voluntarily and sign informed consent forms
Exclusion Criteria:
1. Known allergies to carrilizumab or solfantinib machine components
2. Patients with obstructive jaundice who could not reach the upper limit of TBIL≤2.5
times of normal value after surgical intervention
3. Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks
4. Patients with obvious coagulation mechanism disorder, active bleeding and bleeding
tendency
5. History of other malignancies within 5 years (fully treated basal cell carcinoma of
the skin, cervical cancer in situ)
6. Interstitial pneumonia or pulmonary fibrosis
7. Uncontrollable pleural effusion or ascites
8. Severe uncontrolled medical disease, acute infection, recent history of myocardial
infarction (within 3 months)
9. Pregnant or lactating mothers who refused to take appropriate contraceptive measures
during the course of the study;
10. The researchers determined that the patients were not suitable for this study
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 2023
Completion date:
December 2024
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05697237
