Biliary Tract CancerPhase 2NCT06654947
A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.
A Phase 2 study testing Surufatinib+Toripalimab+GEMOX in people with Biliary Tract Cancer, run by Fujian Cancer Hospital.
Trial summary
This is a single-arm, open-label, prospective clinical study aimed at observing and evaluating the efficacy and safety of surufatinib combined with immunotherapy and chemotherapy in the treatment of unresectable or metastatic biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Surufatinib+Toripalimab+GEMOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have fully comprehended this study and voluntarily signed the Informed Consent Form;
- Age ≥ 18 years;
- Inoperable or metastatic biliary tract carcinoma confirmed by histopathology or cytology;
- Hepatic function classified as Child-Pugh Class A (scores 5-6) or Class B with favorable prognosis (score ≤7) (refer to Appendix 3);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (refer to Appendix 1);
- Anticipated survival ≥ 12 weeks;
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- At least one measurable lesion according to RECIST 1.1 criteria (refer to Appendix 2);
- Essentially normal function of major organs and bone marrow:
- Complete blood count: WBC ≥ 4.0 × 10^9/L, neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L;
- Prothrombin time expressed as International Normalized Ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
- Hepatic function tests: Total bilirubin ≤ 1.5 × ULN; without liver metastasis, ALT/AST/ALP ≤ 2.5 × ULN; with liver metastasis, ALT/AST/ALP ≤ 5 × ULN;
- Renal function tests: Serum creatinine ≤ 1.5 × ULN, and creatinine clearance (CCr) ≥ 60 mL/min (refer to Appendix 6);
- Cardiac function within normal limits, with left ventricular ejection fraction (LVEF) ≥ 50% as determined by two-dimensional echocardiography.
- Male or female patients of reproductive potential voluntarily agree to use effective contraception during the study and for six months following the final administration of study medication, such as dual-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to have reproductive potential unless they have undergone spontaneous menopause, surgically-induced menopause, or have had a hysterectomy, bilateral salpingectomy, or ovarian irradiation with radioisotopes.
Who cannot join
- Patients who relapsed within 6 months after previous immunosuppressive therapy;
- Clinically symptomatic central nervous system metastases and/or carcinomatous meningitis;
- Biliary obstruction that, in the investigator's judgment, has not resolved or requires anti-infective treatment within 14 days prior to the first study drug administration despite clinical intervention;
- History of liver transplantation;
- Active autoimmune disease or immunodeficiency;
- Any surgery or invasive treatment or procedure (excluding venous catheterization, puncture drainage, etc.) within 4 weeks prior to study enrollment;
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- Uncontrolled hypertension not managed with medication, defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg;
- Urinalysis indicating proteinuria ≥2+ and, with a 24-hour urine protein quantification >1.0g;
- Current presence of any disease or condition affecting drug absorption, or the patient's inability to orally ingest sorafenib;
- Current active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases, or active bleeding from an unresected tumor, or other conditions deemed likely to cause gastrointestinal bleeding or perforation by the investigator;
- Active bleeding or severe bleeding tendency;
- Significant clinical cardiovascular disease, including but not limited to acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina, or coronary artery bypass grafting; New York Heart Association (NYHA) classification > grade 2 for congestive heart failure; ventricular arrhythmias requiring drug therapy; electrocardiogram (ECG) showing QTc interval ≥480 milliseconds;
- Active or uncontrolled severe infection (≥Grade 2 infection by CTC AE);
- Known human immunodeficiency virus (HIV) infection; known clinically significant liver disease history, including viral hepatitis [known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (>1×10^4 copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA positive (>1×10^3 copies/mL), or other types of hepatitis, cirrhosis];
- Unresolved toxicities higher than Grade 1 by CTCAE from any previous anticancer treatment, excluding alopecia, lymphocytopenia, and ≤Grade 2 neurotoxicity caused by oxaliplatin (excluding well-controlled immune-related thyroiditis and pituitary inflammation with hormone replacement therapy);
- Pregnant (positive pregnancy test before medication) or breastfeeding women;
- Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities that, in the investigator's judgment, reasonably suspect the patient has a certain disease or condition unsuitable for the use of the study medication (such as epilepsy requiring treatment), or will affect the interpretation of the study results, or place the patient at high risk.
- Received strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study medication;
- A history of malignant tumors other than the current tumor within 5 years prior to screening, except for those with negligible risk of metastasis or death (e.g., overall 5-year survival rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, carcinoma in situ of the breast, or stage I uterine cancer; The investigator deems that the patient has other factors that may affect the study results or lead to premature termination of this study, such as alcohol abuse, drug abuse, other serious diseases (including mental illnesses) requiring concurrent treatment, significant laboratory test abnormalities, accompanied by family or social factors that will affect patient safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a single-arm, open-label, prospective clinical study aimed at observing and evaluating the efficacy and safety of surufatinib combined with immunotherapy and chemotherapy in the treatment of unresectable or metastatic biliary tract cancer.
- Conditions
- Biliary Tract Cancer
- Being tested
- Surufatinib+Toripalimab+GEMOX
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib+Toripalimab+GEMOXDrug
Surufatinib (200mg，qd，Q3W）；Toripalimab(240mg IV d1, Q3W)；GEMOX：Gemcitabine: 1000 mg/m2, IV，d1，d8，Q3W，Oxaliplatin：100mg/m2,ivgtt，d1，Q3W）
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental | Experimental | Not described Receives: Drug: Surufatinib+Toripalimab+GEMOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Secondary outcomes (4)
Objective response rate (ORR)
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Overall survival (OS）
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization until death due to any cause, assessed up to 3 year
Disease control rate (DCR）
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: from first dose to 30 days post the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654947
- Sponsor's protocol ID
- ST-BTC-001
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.
- ClinicalTrials.gov ID
- NCT06654947
- Acronym / sponsor ID
- ST-BTC-001
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Oct 2024 (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-label, prospective clinical study aimed at observing and evaluating the efficacy and safety of surufatinib combined with immunotherapy and chemotherapy in the treatment of unresectable or metastatic biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental | Experimental | Drug: Surufatinib+Toripalimab+GEMOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have fully comprehended this study and voluntarily signed the Informed Consent Form;
- Age ≥ 18 years;
- Inoperable or metastatic biliary tract carcinoma confirmed by histopathology or cytology;
- Hepatic function classified as Child-Pugh Class A (scores 5-6) or Class B with favorable prognosis (score ≤7) (refer to Appendix 3);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (refer to Appendix 1);
Key exclusion criteria (19 listed)
- Patients who relapsed within 6 months after previous immunosuppressive therapy;
- Clinically symptomatic central nervous system metastases and/or carcinomatous meningitis;
- Biliary obstruction that, in the investigator's judgment, has not resolved or requires anti-infective treatment within 14 days prior to the first study drug administration despite clinical intervention;
- History of liver transplantation;
- Active autoimmune disease or immunodeficiency;
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 |
|---|---|---|
| Surufatinib+Toripalimab+GEMOXSurufatinib (200mg，qd，Q3W）；Toripalimab(240mg IV d1, Q3W)；GEMOX：Gemcitabine: 1000 mg/m2, IV，d1，d8，Q3W，Oxaliplatin：100mg/m2,ivgtt，d1，Q3W） | Drug | Experimental: Experimental |
Primary outcome
Progression free survival (PFS)
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
4 secondary outcomes
Objective response rate (ORR)
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Overall survival (OS）
Time frame: from randomization until death due to any cause, assessed up to 3 year
Disease control rate (DCR）
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Time frame: from first dose to 30 days post the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib+Toripalimab+GEMOX in people with Biliary Tract Cancer, run by Fujian Cancer Hospital.
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 14 inclusion and 19 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: opening soon, as of the sponsor's last update on 16 Dec 2024. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sha Hua (13763820570, huangsha0210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year). 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 2024.