Intrahepatic CholangiocarcinomaNCT06313554
Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma
A study testing Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin in people with Intrahepatic Cholangiocarcinoma, run by Fudan University.
Trial summary
This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 20 May 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up;
- Inoperable or metastatic intrahepatic bile duct carcinoma confirmed by histopathology or cytology;
- In accordance with the NCCN guidelines for intrahepatic cholangiocarcinoma diagnosis criteria, intrahepatic cholangiocarcinoma not suitable for radical resection was confirmed: R0 resection could not be obtained, liver was multiple, lymph node metastasis beyond the hepatic portal area and distant metastasis;
- Male or female between the ages of 18 and 75 (including boundary values);
- ECOG score: 0-1; Expected survival ≥12 weeks;
- Liver function Child-Pugh grade A;
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- Have not received systematic treatment for inoperable or metastatic biliary tract cancer; Patients who had received adjuvant or neoadjuvant chemotherapy of one regimen and relapsed 6 months after the end of chemotherapy could be enrolled;
- At least one measurable lesion (according to RECIST 1.1); Magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement were used to accurately measure the diameter of the lesion ≥1cm, and the study target lesion had not previously received local treatment (including but not limited to HIAC, radiofrequency ablation, argon helium knife, radiation therapy and other local treatments);
- No serious organic diseases of heart, lung, brain and other organs;
- The main organs and bone marrow functions are basically normal:
- Blood routine: white blood cells ≥ 4.0 x 109/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 80 x 109/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 ≤ 2 x ULN; ALT/AST ≤ 2 x ULN; Serum albumin ≥28g/L;
- Renal function: serum creatinine ≤ 1.5 x ULN or eGFR≥60%, creatinine clearance (CCr) ≥60mL/min; To rule out urinary system infection, urine routine showed urine protein < 2+, ≥2+ patients should be collected 24 hours of urine protein volume < 1g;
- 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 they have undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or irradiation of radioactive ovaries).
Who cannot join
- Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;
- Patients with a history of TACE treatment and who had previously received any immune or targeted therapy were excluded; Patients with a history of hepatectomy, postoperative recurrence, and no systemic therapy were included
- The investigators determined that liver metastases accounted for 90% or more of the total liver volume;
- Patients who have previously received an organ transplant or are planning an organ transplant;
- Patients with obstructive jaundice but yellowing is not as expected;
- 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;
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- Patients who have had or are currently having any brain metastases;
- Other strong inducers or suppressors of CYP3A4 were taken within 2 weeks prior to the first study;
- Received any surgery (except biopsy) or invasive treatment or operation within 4 weeks before enrollment, and the surgical incision was not completely healed (except intravenous catheterization, puncture drainage, etc.);
- Electrolyte abnormalities identified by the investigator as clinically significant;
- The patient currently has medically uncontrolled hypertension, defined as: 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); People with a history of inherited or acquired bleeding or coagulation disorders. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months prior to enrollment, such as gastrointestinal bleeding and hemorrhagic gastric ulcer;
- 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 QT c interval ≥480 ms;
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
- Unmitigated toxicity higher than CTCAE grade 2 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects 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 which 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, pituitaritis, hyperthyroidism, etc.);
- Known allergic reactions to other monoclonal antibodies or to any component of solvatinib;
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-center, Single-arm, Open-label Clinical Study of Surufatinib Combined With Toripalimab and HAIC in Patients With Inoperable or Metastatic Intrahepatic Cholangiocarcinoma
This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.
The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib、Toripalimab、Gemcitabine、OxaliplatinDrug
The first week dose of Surufatinib was 150mg, the second week and the subsequent cycle was 200 mg once a day (QD) orally, Q3W, and the drug was suspended for one day on the day of HAIC; Toripalimab: 240mg intravenous infusion d1, Q3W;
HAIC: All patients received HAIC treatment on D1. Hepatic arterial perfusion therapy (HAIC) : a treatment cycle every 3 weeks for 4-6 consecutive cycles:
Surufatinib and Toripalimab were administered continuously until intolerable toxicity, disease progression, withdrawal of informed consent, loss of follow-up, and investigator judgment that medication should be discontinued (whichever occurred first).
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib Combined With Toripalimab and HAIC | Experimental | The first week dose of solantinib was 150mg, the second week and the subsequent cycle was 200 mg once a day (QD) orally, Q3W, and the drug was suspended for one day on the day of HAIC;
Toripalimab: 240mg intravenous infusion d1, Q3W;
HAIC: All patients received HAIC treatment on D1. Hepatic arterial perfusion therapy (HAIC) : a treatment cycle every 3 weeks for 4-6 consecutive cycles:
Surufatinib and Toripalimab were administered continuously until intolerable toxicity, disease progression, withdrawal of informed consent, loss of follow-up, and investigator judgment that medication should be discontinued (whichever occurred first). Receives: Drug: Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR objective response rate
objective response rate (ORR)Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: 24 months
Secondary outcomes (4)
Progression-Free Survival(PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first.Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1) as assessed by investigator
Measured: 24 months
OS overall survival
OS is the time from enrollment to death due to any cause.
Measured: 24 months
DCR disease control rate
DCR was defined as the percentage of participants who have a confirmed complete response (CR)or partial response (PR)or stable disease (SD) per RECIST 1.1 as assessed by investigator
Measured: 24 months
Adverse events as assessed by NCI CTCAE v5.0
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 May 2024 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313554
- Sponsor's protocol ID
- HMPL-012-SH-ICC101
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Open-label Clinical Study of Surufatinib Combined With Toripalimab and HAIC in Patients With Inoperable or Metastatic Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06313554
- Acronym / sponsor ID
- HMPL-012-SH-ICC101
- Conditions
- Intrahepatic Cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 15 Mar 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 study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.
The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib Combined With Toripalimab and HAIC | Experimental | Drug: Surufatinib、Toripalimab、Gemcitabine、OxaliplatinThe first week dose of solantinib was 150mg, the second week and the subsequent cycle was 200 mg once a day (QD) orally, Q3W, and the drug was suspended for one day on the day of HAIC; Toripalimab: 240mg intravenous infusion d1, Q3W; HAIC: All patients received HAIC treatment on D1. Hepatic arterial perfusion therapy (HAIC) : a treatment cycle every 3 weeks for 4-6 consecutive cycles: Surufatinib and Toripalimab were administered continuously until intolerable toxicity, disease progression, withdrawal of informed consent, loss of follow-up, and investigator judgment that medication should be discontinued (whichever occurred first). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up;
- Inoperable or metastatic intrahepatic bile duct carcinoma confirmed by histopathology or cytology;
- In accordance with the NCCN guidelines for intrahepatic cholangiocarcinoma diagnosis criteria, intrahepatic cholangiocarcinoma not suitable for radical resection was confirmed: R0 resection could not be obtained, liver was multiple, lymph node metastasis beyond the hepatic portal area and distant metastasis;
- Male or female between the ages of 18 and 75 (including boundary values);
- ECOG score: 0-1; Expected survival ≥12 weeks;
Key exclusion criteria (23 listed)
- Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;
- Patients with a history of TACE treatment and who had previously received any immune or targeted therapy were excluded; Patients with a history of hepatectomy, postoperative recurrence, and no systemic therapy were included
- The investigators determined that liver metastases accounted for 90% or more of the total liver volume;
- Patients who have previously received an organ transplant or are planning an organ transplant;
- Patients with obstructive jaundice but yellowing is not as expected;
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、Gemcitabine、OxaliplatinThe first week dose of Surufatinib was 150mg, the second week and the subsequent cycle was 200 mg once a day (QD) orally, Q3W, and the drug was suspended for one day on the day of HAIC; Toripalimab: 240mg intravenous infusion d1, Q3W; HAIC: All patients received HAIC treatment on D1. Hepatic arterial perfusion therapy (HAIC) : a treatment cycle every 3 weeks for 4-6 consecutive cycles: Surufatinib and Toripalimab were administered continuously until intolerable toxicity, disease progression, withdrawal of informed consent, loss of follow-up, and investigator judgment that medication should be discontinued (whichever occurred first). | Drug | Surufatinib Combined With Toripalimab and HAIC |
Primary outcome
ORR objective response rate
Time frame: 24 months
objective response rate (ORR)Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
4 secondary outcomes
Progression-Free Survival(PFS)
Time frame: 24 months
OS overall survival
Time frame: 24 months
DCR disease control rate
Time frame: 24 months
Adverse events as assessed by NCI CTCAE v5.0
Time frame: 24 months
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 15 Mar 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin in people with Intrahepatic Cholangiocarcinoma, run by Fudan University.
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 23 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 15 Mar 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.
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 Lu Wang (136 0167 8615, cms024mm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR objective response rate (time frame: 24 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 15 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.