CarcinomaPhase 2NCT06134193
Combination Therapy of HAIC, Surufatinib and Tislelizumab for Unresectable or Metastatic Biliary Tract Cancer
A Phase 2 study testing HAIC, Surufatinib and Tislelizumab in people with Carcinoma and Intrahepatic Cholangiocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with surufatinib and tislelizumab in the first line treatment of patients with unresectable or metastatic biliary tract cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Intrahepatic Cholangiocarcinoma, Gallbladder Cancer
- What is being tested?
- HAIC, Surufatinib and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jun 2025
- 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
- 1. Written informed consent should be signed before implementing any trial-related procedures 2. Patients with age ≥18 years ,≤75 years old. 3. ECOG PS scores 0-1 4. Histologically/cytologically confirmed unresectable or metastatic Intrahepatic Cholangiocarcinoma and gallbladder cancer 5. Child Pugh stage A 6. Estimated survival > 12 weeks 7. According to the diagnostic criteria of NCCN(National Comprehensive Cancer Network ) guidelines for intrahepatic cholangiocarcinoma and gallbladder cancer, the patients were diagnosed as intrahepatic cholangiocarcinoma and gallbladder cancer not suitable for radical resection: unable to obtain R0 resection, multiple liver, beyond hilar lymph node metastasis and distant metastasis 8. No systemic therapy for unresectable or metastatic biliary tract cancer; Patients who had received one regimen of adjuvant therapy and had a relapse more than 6 months after the end of chemotherapy were eligible.
- 9. At least one measurable lesion according to RECIST V1.1 The diameter of the target lesion was ≥1cm as accurately measured by enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT), and the study target lesion had not received previous local treatment (including but not limited to HAIC, radiofrequency ablation, argon-helium knife, radiotherapy, and other local treatment methods) 10. Sufficient organ and bone marrow functions, with the laboratory test values within 14 days before the enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other drugs via intravenous or subcutaneous administrations are allowed for correction treatment within the first 14 days after the laboratory test results are obtained). The specific information is as follows:
- Routine blood test: white blood cell ≥ 4.0 × 109/L absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 80 × 109/L; hemoglobin (HGB) ≥ 9.0 g/dL.
- Hepatic function: total bilirubin (TBIL) ≤ 3 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN.
- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or eGFR≥60%,clearance of creatinine (CCr) ≥ 60 mL/min (Cockcroft Gault formula);
- Blood coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Normal cardiac function with left ventricular ejection fraction (LVEF)≥50% measured by two-dimensional echocardiography; 11. Patients were eligible for HAIC surgery as prespecified by the study center, without any contraindications, and could receive HAIC treatment.
- 12. Male or female patients of childbearing potential volunteered to use an effective method of contraception, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study and for 6 months after the last study medication. "All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnophorectomy, or radioactive ovarian irradiation)."
Who cannot join
- 1. Participated in other clinical trials of antineoplastic drugs within 4 weeks before enrollment.
- 2. History of liver resection, TACE treatment, and any previous immune or targeted therapy; 3. Liver metastases of 70% or more of the total liver volume as determined by the investigator.
- 4. History of prior or planned any organ transplantation. 5. Patients with obstructive jaundice who did not reduce jaundice as expected. 6. Other malignant tumors in the past 5 years, excluding basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix.
- 7. Patients with confirmed or suspected symptomatic active brain or meningeal metastases.
- 8. Received any surgery (except biopsy) or invasive treatment or operation within 4 weeks before enrollment and the surgical incision was not completely healed (except venous catheterization, puncture drainage, etc.).
- 9. Electrolyte abnormalities that were judged by the investigator to be clinically significant..
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- 10. Patients have current drug-uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg.
- 11. Urine routine test showed urinary protein ≥2+, and 24 h urinary protein amount >1.0g.
- 12. Patients whose tumors were judged by the investigator to be highly likely to invade vital blood vessels and cause fatal bleeding during the follow-up study.
- 13. Patients with evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding within 3 months >30 mL, hematemesis, melena, hematochezia), hemoptysis (within 4 weeks>5 mL of fresh blood); Patients with a history of hereditary or acquired bleeding or coagulopathy. Patients had clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.
- 14. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; New York Heart Association (NYHA) classification of congestive heart failure >Grade 2; Ventricular arrhythmias requiring medical therapy; Electrocardiogram (ECG) showed QT c interval ≥480 msec.
- 15. Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding.
- 16. Any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality in which there is reason to suspect that the patient has a disease or condition (e.g., having seizures requiring treatment) that would be inappropriate for use of the study drug, or that would affect interpretation of the study results or place the patient at high risk, in the investigator's judgment.
- 17. Severe active or uncontrolled infection (≥CTCAE grade 2 infection), known human immunodeficiency virus (HIV) infection; Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (> 1×104 copies /mL or >2000 IU/ mL), known hepatitis C virus (HCV) infection with positive HCV RNA (>1×103 copies /mL), or other hepatitis, cirrhosis.
- 18. Patients with 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, hypophysitis, hyperthyroidism, etc.) Patients with 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, hypophysitis, hyperthyroidism, etc).
- 19. Known allergic reactions to other monoclonal antibodies or to any component of surufatinib.
- 20. According to the investigator's judgment, patients have other factors that may affect the results of the study or lead to the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment, family or social factors, etc., which will affect the safety of patients.
Trial locations and contacts
No sites are listed yet.
About this study
This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with surufatinib and tislelizumab in the first line treatment of patients with unresectable or metastatic biliary tract cancer
- Conditions
- Carcinoma, Intrahepatic Cholangiocarcinoma, Gallbladder Cancer, Surufatinib, Angiogenesis Inhibitors, Tislelizumab
- Being tested
- HAIC, Surufatinib, Tislelizumab
- Medical subject headings
- Carcinoma, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAICDrug
hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil, leucovorin (FOLFOX) treatment (Q3W) Oxaliplatin: 85mg/m2 , Day 1 Leucovorin: 200mg/m2, Day 1 Fluorouracil: 400mg/m2, Day1 and 2400mg/m2 continuous arterial perfusion for 46h.
SurufatinibDrug
250mg PO d1, Q3W
TislelizumabDrug
200mg IV d1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| HAIC, surufatinib and tislelizumab | Experimental | Not described Receives: Drug: HAIC; Drug: Surufatinib; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival (PFS) per RECIST v1.1
Defined as a duration from the date of initial treatment to disease progression or death of any cause
Measured: From baseline to primary completion date, about 18 months
Secondary outcomes (5)
Overall response rate (ORR) per RECIST v1.1 and mRECIST
Defined as the sum of the complete response and partial response rate
Measured: From baseline to primary completion date, about 3 months
Disease control rate (DCR) per RECIST v1.1 and mRECIST
Defined as the sum of the complete response, partial response and stable disease
Measured: From baseline to primary completion date, about 3 months
Overall survival (OS)
Defined as a duration from the date of initial treatment to death of any cause
Measured: From baseline to primary completion date, about 24 months
Conversion to surgical resection rate
Defined as the proportion of patients who were successfully converted to radical resection with negative hepatic margins after the study treatment regimen was calculated
Measured: From baseline to primary completion date, about 6 months
Incidence rate of adverse events
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Measured: From baseline to primary completion date, about 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 41 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Liang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134193
- Sponsor's protocol ID
- UHCT230436
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of HAIC, Surufatinib and Tislelizumab for Unresectable or Metastatic Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06134193
- Acronym / sponsor ID
- UHCT230436
- Conditions
- Carcinoma, Intrahepatic Cholangiocarcinoma, Gallbladder Cancer, Surufatinib, Angiogenesis Inhibitors, Tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Nov 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.
This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with surufatinib and tislelizumab in the first line treatment of patients with 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 |
|---|---|---|
| HAIC, surufatinib and tislelizumab | Experimental | Drug: HAIC, Drug: Surufatinib, Drug: Tislelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Written informed consent should be signed before implementing any trial-related procedures 2. Patients with age ≥18 years ,≤75 years old. 3. ECOG PS scores 0-1 4. Histologically/cytologically confirmed unresectable or metastatic Intrahepatic Cholangiocarcinoma and gallbladder cancer 5. Child Pugh stage A 6. Estimated survival > 12 weeks 7. According to the diagnostic criteria of NCCN(National Comprehensive Cancer Network ) guidelines for intrahepatic cholangiocarcinoma and gallbladder cancer, the patients were diagnosed as intrahepatic cholangiocarcinoma and gallbladder cancer not suitable for radical resection: unable to obtain R0 resection, multiple liver, beyond hilar lymph node metastasis and distant metastasis 8. No systemic therapy for unresectable or metastatic biliary tract cancer; Patients who had received one regimen of adjuvant therapy and had a relapse more than 6 months after the end of chemotherapy were eligible.
- 9. At least one measurable lesion according to RECIST V1.1 The diameter of the target lesion was ≥1cm as accurately measured by enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT), and the study target lesion had not received previous local treatment (including but not limited to HAIC, radiofrequency ablation, argon-helium knife, radiotherapy, and other local treatment methods) 10. Sufficient organ and bone marrow functions, with the laboratory test values within 14 days before the enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other drugs via intravenous or subcutaneous administrations are allowed for correction treatment within the first 14 days after the laboratory test results are obtained). The specific information is as follows:
- 12. Male or female patients of childbearing potential volunteered to use an effective method of contraception, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study and for 6 months after the last study medication. "All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnophorectomy, or radioactive ovarian irradiation)."
Key exclusion criteria (17 listed)
- 1. Participated in other clinical trials of antineoplastic drugs within 4 weeks before enrollment.
- 2. History of liver resection, TACE treatment, and any previous immune or targeted therapy; 3. Liver metastases of 70% or more of the total liver volume as determined by the investigator.
- 4. History of prior or planned any organ transplantation. 5. Patients with obstructive jaundice who did not reduce jaundice as expected. 6. Other malignant tumors in the past 5 years, excluding basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix.
- 7. Patients with confirmed or suspected symptomatic active brain or meningeal metastases.
- 8. Received any surgery (except biopsy) or invasive treatment or operation within 4 weeks before enrollment and the surgical incision was not completely healed (except venous catheterization, puncture drainage, etc.).
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 |
|---|---|---|
| HAIChepatic arterial infusion (HAI) of oxaliplatin, fluorouracil, leucovorin (FOLFOX) treatment (Q3W) Oxaliplatin: 85mg/m2 , Day 1 Leucovorin: 200mg/m2, Day 1 Fluorouracil: 400mg/m2, Day1 and 2400mg/m2 continuous arterial perfusion for 46h. | Drug | HAIC, surufatinib and tislelizumab |
| Surufatinib250mg PO d1, Q3W | Drug | HAIC, surufatinib and tislelizumab |
| Tislelizumab200mg IV d1, Q3W | Drug | HAIC, surufatinib and tislelizumab |
Primary outcome
Progress free survival (PFS) per RECIST v1.1
Time frame: From baseline to primary completion date, about 18 months
Defined as a duration from the date of initial treatment to disease progression or death of any cause
5 secondary outcomes
Overall response rate (ORR) per RECIST v1.1 and mRECIST
Time frame: From baseline to primary completion date, about 3 months
Disease control rate (DCR) per RECIST v1.1 and mRECIST
Time frame: From baseline to primary completion date, about 3 months
Overall survival (OS)
Time frame: From baseline to primary completion date, about 24 months
Conversion to surgical resection rate
Time frame: From baseline to primary completion date, about 6 months
Incidence rate of adverse events
Time frame: From baseline to primary completion date, about 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAIC, Surufatinib and Tislelizumab in people with Carcinoma and Intrahepatic Cholangiocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 8 inclusion and 17 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 18 Nov 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.
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?
Contact Bin Liang (86-18086006235, 553954881@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (PFS) per RECIST v1.1 (time frame: From baseline to primary completion date, about 18 months). 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 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.