Trial Title:
SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma
NCT ID:
NCT06199882
Condition:
Biliary Tract Carcinoma
Conditions: Official terms:
Carcinoma
Immunomodulating Agents
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Suspended
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SBRT Sequential Surufatinib Combined With Immunotherapy
Description:
1. SBRT :
Bioequivalent total dose > 75Gy, completed within 2 weeks (once daily, 5 times a
week).
2. Drug treatment (every 3 weeks is a treatment cycle) :
1) Surufatinib: 200 mg, po, qd, taken continuously; 2) Carrelizumab: 200 mg/ time,
intravenous drip on the first day of each cycle.
Arm group label:
SBRT Sequential Surufatinib Combined With Immunotherapy
Other name:
SBRT--Surufatinib+Carrelizumab
Summary:
This is a single-arm, open, single-center Phase II clinical study to observe and evaluate
the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in
patients with locally unresectable or recurrent biliary tract cancer after the first
surgery.
Detailed description:
This is a single-arm, open, single-center Phase II clinical study to observe and evaluate
the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in
patients with locally unresectable or recurrent biliary tract cancer after the first
surgery.The study was divided into three stages: screening period, treatment period and
follow-up period. During treatment, imaging methods were used to evaluate tumor status
every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during
treatment) or toxicity became intolerable, and tumor treatment and survival status after
disease progression were recorded. Safety outcome measures included AE, changes in
laboratory test values, vital signs and electrocardiogram changes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- To be enrolled in this study, patients must meet all of the following criteria:
1. The subjects voluntarily joined the study and signed the informed consent, with
good compliance and follow-up;
2. Age 18-75 years old (including 18 and 75 years old), gender is not limited;
3. Patients with unresectable or untreated recurrent BTC confirmed by
histopathology or cytology (including intrahepatic, extrahepatic, and
gallbladder cancers);
4. Have not received any anti-tumor therapy before;
5. Have at least one measurable lesion (according to RECIST 1.1 standards);
Magnetic resonance imaging (MRI) enhancement or computed tomography (CT)
enhancement were used to accurately measure the diameter ≥10mm, and
conventional CT scan was used to measure the diameter at least 20mm.
6. Normal liver volume (total liver volume minus tumor GTV volume) exceeds 1000cc;
7. The maximum diameter of the tumor is less than 10cm, allowing up to 3 satellite
foci. Satellite foci were defined as being less than 2cm and within 1cm of the
gross tumor.
8. No serious organic diseases of heart, lung, brain and other organs;
9. The main organs and bone marrow functions are basically normal:
1. Blood routine: white blood cells ≥ 4.0 x 10^9/L, neutrophils ≥ 1.5 x 10^9/L,
platelets ≥ 80 x 10^9/L, hemoglobin ≥ 90g/L;
2. International Standardized ratio (INR) and activated partial thromboplastin
time (APTT) ≤1.5× upper limit of normal (ULN);
3. Liver function: serum total bilirubin ≤ 1.5 x ULN, ALT/AST ≤ 3 x ULN, serum
total bilirubin ≤ 1.5 x ULN after internal/external drainage of obstructive
jaundice;
4. Renal function: serum creatinine ≤ 1.5x ULN, creatinine clearance (CCr) ≥
50mL/min;
5. Normal cardiac function with left ventricular ejection fraction (LVEF)≥50% as
measured by two-dimensional echocardiography; Fertile male or female patients
volunteered to use effective contraceptive methods, such as double barrier
methods, condoms, oral or injectable contraceptives, and Iuds, during the study
period and within 6 months of the last study medication. All female patients
will be considered fertile unless the woman has undergone natural menopause,
artificial menopause or sterilization.
Exclusion Criteria:
- The study proposal shall be excluded if any of the following criteria are met:
1. Have received any antitumor therapy in the past (except simple surgical
resection);
2. The tumor directly invades the stomach, small intestine or colon;
3. The maximum diameter of the lesion exceeds 10cm, or the satellite lesion does
not meet the above definition criteria;
4. Have had other malignancies within the past 5 years, except basal cell or
squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ
of the cervix;
5. There are extra-hepatic metastases (excluding local regional lymph nodes);
6. Normal liver volume is less than 1000cc;
7. The patient currently has hypertension that cannot be controlled by drugs, as
follows: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90
mmHg;
8. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume
>1.0g;
9. Patients whose tumors are judged by the investigators to be at high risk of
invading vital blood vessels and causing fatal massive bleeding during the
follow-up study;
10. Patients with evidence or history of significant bleeding tendency within 3
months prior to enrollment (bleeding within 3 months> 30 mL, hematemesis,
stool, stool blood), hemoptysis (within 4 weeks > 5 mL fresh blood); Patients
with a history of hereditary or acquired bleeding or coagulation disorders have
clinically significant bleeding symptoms or definite bleeding tendencies within
3 months, such as gastrointestinal bleeding and hemorrhagic gastric ulcers;
11. Clinically significant cardiovascular disease, including but not limited to
acute myocardial infarction, severe/unstable angina pectoris, or coronary
artery bypass grafting within 6 months prior to enrollment; New York Heart
Association (NYHA) Grades for Congestive Heart Failure >Level 2; Ventricular
arrhythmias requiring medical treatment; Electrocardiogram (ECG) showed QTC
interval ≥480 ms.
12. Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
13. Women who are pregnant (positive pregnancy test before medication) or
breastfeeding;
14. Any other medical condition, clinically significant metabolic abnormality,
physical abnormality or laboratory abnormality, in which, in the investigator's
judgment, there is reason to suspect that the patient has a medical condition
or condition that is not suitable for the use of the investigational drug (such
as having seizures and requiring treatment), or that would affect the
interpretation of the study results or place the patient at high risk;
15. Known human immunodeficiency virus (HIV) infection; Known history of clinically
significant liver disease, including viral hepatitis [Known hepatitis B virus
(HBV) carriers must rule out active HBV infection, i.e., positive HBV DNA
(>1×104 copies /mL or >2000 IU/ml); known hepatitis C virus infection (HCV) and
HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis];
16. The presence of any active, known or suspected autoimmune disease (including
but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic
lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis,
vasculitis, glomerulonephritis, uveitis, pituitaries, hyperthyroidism, etc.);
17. Allergy or suspected allergy to the investigational drug or similar drugs;
According to the investigators' judgment, the patients had other factors that
might affect the study results or lead to the forced termination of the study,
such as alcoholism, drug abuse, other serious diseases (including mental
illness) requiring combined treatment, serious laboratory abnormalities, and
family or social factors that would affect the safety of the patients.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Liu luying
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Start date:
February 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06199882
