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Biliary Tract CarcinomaPhase 2NCT06199882

SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma

A Phase 2 study testing SBRT Sequential Surufatinib Combined With Immunotherapy in people with Biliary Tract Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Carcinoma
What is being tested?
SBRT Sequential Surufatinib Combined With Immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
1 Feb 2024to 30 Jun 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be enrolled in this study, patients must meet all of the following criteria:
  • The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up;
  • Age 18-75 years old (including 18 and 75 years old), gender is not limited;
  • Patients with unresectable or untreated recurrent BTC confirmed by histopathology or cytology (including intrahepatic, extrahepatic, and gallbladder cancers);
  • Have not received any anti-tumor therapy before;
  • 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.
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  • Normal liver volume (total liver volume minus tumor GTV volume) exceeds 1000cc;
  • 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.
  • No serious organic diseases of heart, lung, brain and other organs;
  • The main organs and bone marrow functions are basically normal:
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  • 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;
  • International Standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5× upper limit of normal (ULN);
  • 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;
  • Renal function: serum creatinine ≤ 1.5x ULN, creatinine clearance (CCr) ≥ 50mL/min;
  • 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.

Who cannot join

  • The study proposal shall be excluded if any of the following criteria are met:
  • Have received any antitumor therapy in the past (except simple surgical resection);
  • The tumor directly invades the stomach, small intestine or colon;
  • The maximum diameter of the lesion exceeds 10cm, or the satellite lesion does not meet the above definition criteria;
  • 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;
  • There are extra-hepatic metastases (excluding local regional lymph nodes);
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  • Normal liver volume is less than 1000cc;
  • 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;
  • Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume >1.0g;
  • 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;
  • 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;
  • 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.
  • Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
  • Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
  • 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;
  • 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];
  • 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.);
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Liu luying

    Hangzhou, Zhejiang, 310022

Other trials in China

About this study

Official title: A Single-arm, Open, Single-center Phase II Clinical Study on the Efficacy and Safety of SBRT Sequential Surufatinib Combined With Immunotherapy for Locally Unresectable or Recurrent Biliary Tract Cancer After First Surgery

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.

Read the 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.

Being tested
SBRT Sequential Surufatinib Combined With Immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRT Sequential Surufatinib Combined With ImmunotherapyDrug

    Also called SBRT--Surufatinib+Carrelizumab

    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) :
    3. Surufatinib: 200 mg, po, qd, taken continuously; 2) Carrelizumab: 200 mg/ time, intravenous drip on the first day of each cycle.
Study groups in NCT06199882
Study groupRoleWhat they receive
SBRT Sequential Surufatinib Combined With ImmunotherapyExperimentalSBRT : Bioequivalent total dose > 75Gy, completed within 2 weeks (once daily, 5 times a week). 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.
Receives: Drug: SBRT Sequential Surufatinib Combined With Immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate(ORR)

    The proportion of subjects in the analyzed population who developed complete response (CR) and partial response (PR) according to RECIST (version 1.1) criteria.

    Measured: up to 12 months

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    Refers to the date from the date of admission to the date of the first progression of disease or death of any cause

    Measured: up to 12 months

  2. Local control rate (LCR)

    The percentage of confirmed cases with complete response (CR), partial response (PR), and stable disease (SD) in patients for whom efficacy could be evaluated

    Measured: up to 12 months

  3. Overall survival (OS)

    The time interval between the start date of study drug and the date of death (any cause)

    Measured: up to 36 months

  4. Incidence of adverse events （AE）

    Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular forma

    Measured: Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start1 Feb 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Why it stopped: Patient recruitment difficulties

Resources

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
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06199882
Sponsor's protocol ID
2023-383
Status last verified
Oct 2024
First submitted
29 Dec 2023
Last updated
15 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT Sequential Surufatinib Combined With Immunotherapy in people with Biliary Tract Carcinoma, run by Zhejiang Cancer Hospital 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 16 inclusion and 18 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: paused, as of the sponsor's last update on 15 Oct 2024. 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: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06199882.

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 15 Oct 2024.

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