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Intrahepatic CholangiocarcinomaPhase 2CCGLC-005NCT05236699

A Clinical Study of DEB-TACE Combined With Surufatinib and Camrelizumab in the Treatment of Inoperable or Metastatic ICC

A Phase 2 study testing DEB-TACE combined with Surufatinib and Camrelizumab in people with Intrahepatic Cholangiocarcinoma, run by Tongji Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

At present, for advanced Intrahepatic Cholangiocarcinoma（ICC）, the effect of single treatment is not good.So far, superselective drug-eluting bead transarterial chemoembolization（DEB-TACE） is a good method for the treatment of local lesions in advanced ICC.Studies have shown that the combination of sovantinib and… 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?
DEB-TACE combined with Surufatinib and Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
1 Feb 2022to 31 Jan 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

  • The subjects voluntarily joined the study and signed an informed consent form with good compliance and follow-up.
  • Inoperable or metastatic intrahepatic cholangiocarcinoma diagnosed by histopathology or cytology;
  • In accordance with the diagnostic criteria of NCCN guidelines for intrahepatic cholangiocarcinoma, the diagnosis of intrahepatic cholangiocarcinoma that is not suitable for radical resection: unable to obtain R0 resection, multiple liver, lymph node metastasis beyond the hilar area and distant metastasis;
  • ECOG score: 0-1; expected survival ≥ 12 weeks;
  • Liver function Child-Pugh A grade
  • Patients who have not received systematic treatment for unresectable or metastatic biliary tract cancer; those who have received adjuvant or neoadjuvant chemotherapy and relapse 6 months after the end of chemotherapy can be enrolled in the group.
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  • At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cm was accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and the target lesion had not received local treatment in the past (including not limited to hepatic arterial Infusion chemotherapy, radiofrequency ablation, argon-helium knife, radiotherapy, etc.);
  • No serious organic diseases of heart, lung, brain and other organs;
  • The functions of major organs and bone marrow are basically normal:
  • Blood routine: WBC ≥ 4.0x10^9/L, neutrophils ≥ 1.5x10^9/L, platelets ≥ 80x10^9/L, hemoglobin ≥ 90 g/L
  • International standardized ratio (INR) ≤ 1.5 × upper limit of normal value (ULN), and activated partial thromboplastin time (APTT) ≤ 6sbot
  • liver function: serum total bilirubin ≤ 2xULN ;ALT/ AST ≤ 2xULN; serum albumin ≥ 28g/L.
  • Renal function: serum creatinine ≤ 1.5xULN or eGFR ≥ 60%, and creatinine clearance rate (CCr) 60ml / min; excluding urinary tract infection, urine routine showed that urinary protein < 2+, 24-hour urine protein should be collected from ≥ 2 + patients < 1g
  • cardiac function was normal, left ventricular ejection fraction (LVEF) ≥ 50% detected by two-dimensional echocardiography.
  • Fertile male or female patients voluntarily used effective contraceptive methods during the study period and within 6 months of the last study, such as double barrier contraceptives, condoms, oral or injection contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation).
  • Puncture biopsy to determine tumor pathology type as ICC.

Who cannot join

  • Participated in clinical trials of other antineoplastic drugs within 4 weeks before entering the group.
  • Received any surgery or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before the start of the group;
  • History of hepatectomy, history of TACE treatment, previous immune and targeted therapy;
  • gene sequencing identified alterations in FGFR2, such as fusions or rearrangements；
  • The researchers determined that liver metastases accounted for 70% or more of the total liver volume;
  • Patients who have previously received organ transplants or planned organ transplants;
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  • Patients with obstructive jaundice but not as expected;
  • Suffered from other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ;
  • Patients who have had any brain metastases or are currently suffering from brain metastases;
  • In the first study, he took other strong inducers or inhibitors of CYP3A4 within 2 weeks before medication;
  • Received any operation (except biopsy) or invasive treatment or operation within 4 weeks before the start of the group, and the surgical incision did not completely heal (except venous catheterization, puncture and drainage, etc.);
  • The researchers judged clinically significant electrolyte abnormalities;
  • At present, the patients have hypertension that cannot be controlled by drugs, which is defined as systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg.
  • Urine routine showed that the amount of urinary protein was more than 2 grams and the amount of 24-hour urinary protein was more than 1.0 g.
  • The researchers determined that during the follow-up study, the tumor was most likely to invade important blood vessels and cause fatal massive bleeding;
  • Patients with obvious evidence or history of bleeding tendency within 3 months (bleeding > 30 mL within 3 months, hematemesis, black feces, hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), hereditary or acquired history of bleeding or coagulation dysfunction. There were significant clinical bleeding symptoms or definite bleeding tendency in the first 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.;
  • Cardiovascular diseases with significant clinical significance, including, but not limited to, acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; congestive heart failure New York Heart Association (NYHA) grade > 2; ventricular arrhythmias requiring medication; electrocardiogram (ECG) showed QTc interval ≥ 480ms;
  • Active or uncontrolled severe infection (≥ （Common Terminology Criteria for Adverse Events）CTCAE 2 grade infection);
  • Due to any unalleviated toxicity higher than CTCAE 1 grade caused by any previous anticancer therapy, excluding alopecia, lymphocytopenia and oxaliplatin-induced neurotoxicity ≤ 2;
  • Women who are pregnant (positive for pre-medication pregnancy test) or breastfeeding;
  • Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the researchers, there is reason to suspect that the patient has a disease or state that is not suitable for the use of research drugs (such as having seizures and requiring treatment), or will affect the interpretation of the results of the study, or put the patient at high risk;
  • Known human immunodeficiency virus (HIV) infection
  • Patients with any active, known or suspected autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.)
  • Known to have allergic reactions to other monoclonal antibodies or to any component of sovantinib;
  • The researchers judged that patients have other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, and other serious diseases (including mental illness) that need to be combined with treatment. there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Single-arm, Multicenter II Phase Clinical Study of DEB-TACE Combined With Surufatinib and Camrelizumab in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma

At present, for advanced Intrahepatic Cholangiocarcinoma（ICC）, the effect of single treatment is not good.So far, superselective drug-eluting bead transarterial chemoembolization（DEB-TACE） is a good method for the treatment of local lesions in advanced ICC.Studies have shown that the combination of sovantinib and immunotherapy has also shown encouraging results, and patients are well tolerated.Therefore, we designed DEB-TACE combined with Surufatinib and Camrelizumab for the exploratory study of inoperable or metastatic ICC, in order to provide a safe, effective and tolerable option for patients with ICC, prolong their survival time and improve their quality of life.

Read the detailed description

Study design:

This is a single-arm, open, multicenter II phase clinical study to compare the efficacy and safety of DEB-TACE combined with Surufatinib and Camrelizumab in the treatment of inoperable or metastatic ICC.

Study population:

20 untreated patients with inoperable or metastatic intrahepatic cholangiocarcinoma

Treatment:

  1. All patients were treated with standard DEB-TACE on the first day (D1).
  2. Immediately after the first DEB-TACE, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1).
  3. Surufatinib capsule was given orally to 250mg within 1 hour after breakfast on the second day (D2) after the first DEB-TACE. The drug was given continuously once a day and stopped on the same day of each DEB-TACE.
  4. The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study.

Curative effect evaluation： The tumor condition was evaluated by imaging method at D28 (±7 days) after each DEB-TACE, until the curative effect was evaluated as PD or unsuitable for further treatment. After 3 times of DEB-TACE treatment, the tumor efficacy was evaluated every 12 weeks (±7 days) from 6 months after the first DEB-TACE treatment until disease progression (Response Evaluation Criteria In Solid Tumors（RECIST）1.1) or death (during treatment) or toxicity intolerable. The tumor treatment and survival status after disease progression were recorded.

Being tested
DEB-TACE combined with Surufatinib and Camrelizumab
Keywords
DEB-TACE, Surufatinib, Camrelizumab
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • DEB-TACE combined with Surufatinib and CamrelizumabCombination product

    1. All patients will be treated with standard DEB-TACE on the first day (D1).
    2. After DEB-TACE, if the liver function is Child-PughA grade, they will be treated with Camrelizumab on the same day, 200mg/ times, intravenous injection, once every 3 weeks.
    3. Surufatinib capsule will be given orally to 250mg within 1 hour after breakfast on the second day (D2) after the first DEB-TACE. The drug will be given continuously once a day and stopped on the same day of each DEB-TACE.
    4. The combination of drugs for 3 weeks is a cycle.The treatment will continue until the patient developed the disease or met the other criteria for terminating the study.
Study groups in NCT05236699
Study groupRoleWhat they receive
DEB-TACE combined with Surufatinib and CamrelizumabExperimentalNot described
Receives: Combination Product: DEB-TACE combined with Surufatinib and Camrelizumab

What is being measured

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

  1. Objective remission rate (ORR)

    Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR).

    Measured: After the first DEB-TACE treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 1 year

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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  2. Disease control rate (DCR)

    Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  3. Total Survival time (OS)

    Refers to the date from the date of admission to the date of death of any cause

    Measured: Through study completion, an average of 1 year

  4. Incidence of adverse events and toxicities of Surufatinib in combination with Camrelizumab

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

    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 posted11 Feb 2022
  2. Study start1 Feb 2022
  3. Primary completion30 Jun 2024
  4. Study completion31 Jan 2025

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236699
Sponsor's protocol ID
HMPL-012-SPRING-B105
Acronym
CCGLC-005
Status last verified
Feb 2025
First submitted
24 Oct 2021
Last updated
14 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guo B, Fan Y, Li D, Xia F, Luo C, Zhu J, Wu Y, Zhu Z, Xiang S, Liu E, Zhang W. Locoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma. Cell Rep Med. 2025 Dec 16;6(12):102482. doi: 10.1016/j.xcrm.2025.102482. Epub 2025 Dec 4.

    PubMed 41349529

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DEB-TACE combined with Surufatinib and Camrelizumab in people with Intrahepatic Cholangiocarcinoma, run by Tongji 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 25 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: finished, as of the sponsor's last update on 14 Feb 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 remission rate (ORR) (time frame: After the first DEB-TACE treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 1 year). 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 NCT05236699, which also lists 1 linked publication.

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 14 Feb 2025.

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