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Hepatocellular CarcinomaPhase 2NCT05171439

Surufatinib in Advanced Hepatocellular Carcinoma Based on Single-cell Sequencing of Tumor Samples

A Phase 2 study testing Surufatinib in people with Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm, single-center, open-label phase II study designed to assess the efficacy of surufatinib in participants with advanced hepatocellular carcinoma based on single-cell sequencing of tumor samples. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Surufatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
1 Mar 2022to 1 Mar 2023
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

  • Ages: 18-75 Years（concluding 18 and 75 Years）;
  • Radiologically, histologically or cytologically confirmed hepatocellular carcinoma (HCC) with punctable lesions;
  • Barcelona Clinic Liver Cancer stage Category B or C
  • ECOG PS 0-1, there was no deterioration within 7 days;
  • Liver function status Child-Pugh Class A or B (score≤7)
  • Has life expectancy of greater than 12 months；
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  • HCC patients who received first-line standard chemotherapy (systemic chemotherapy with single or combination drugs such as oxaliplatin) and/or molecular targeted therapies such as sorafenib that failed or were not tolerated;
  • Have measurable lesions (according to RECIST 1.1);
  • The main organ functions meet the following criteria: (without blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment): Absolute Neutrophil Count (ANC)≥1.5×109/L Platelet Count of ≥100×109/L； Hemoglobin≥90g/L； Total Bilirubin (TBIL)≤1.5 x ULN； ALB≥29 g/L； ALT、AST and ALP≤5 x ULN； Creatinine（Cr）≤1.5×ULN (or creatinine clearance (CCr)≥ 60mL/min); (Only one of albumin and bilirubin in child-Pugh score can be 2 points)
  • Male or females patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injected birth control medication or intrauterine device, during the study and within 90 days after study treatment discontinuation. All female patients are considered to be fertile, unless the patient had natural menopause or artificial menopause or sterilization (such as hysterectomy, bilateral oophorectomy or ovarian irradiation).
  • Good compliance and follow-up

Who cannot join

  • Hepatobiliary duct cell carcinoma and mixed cell carcinoma and fibrolaminar cell carcinoma；
  • Patients who intend to undergo liver transplantation (except those who have previously undergone liver transplantation) ;
  • Patients who have previously received surufatinib；
  • A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
  • Received investigational treatments in other clinical studies within 4 weeks prior to enrollment;
  • Use of approved systematic anti-tumor therapy within 4 weeks prior to the first dose, including chemotherapy, biotherapy, targeted therapy (the washout period of small molecular targeted drugs lasts 2 weeks or 5 half-lives, whichever is shorter), hormone therapy, treatments with traditional Chinese medicine (for patients receiving treatments with traditional Chinese medicine with clear anti-tumor indications, for anti-tumor indications clearly specified in the package insert, one-week washout period prior to the first dose is acceptable), etc;
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  • Received any surgical or invasive treatment or operation (except intravenous catheterization, abdominal puncture and drainage, etc.) within 4 weeks before enrollment;
  • International normalized ratio(INR) >1.5 or activated partial thromboplastin time(APTT) >1.5×ULN;
  • Presence of clinically significant electrolyte abnormality judged by the investigator;
  • Hypertension that is not controlled by the drug, and is defined as: SBP ≥140 mmHg and/or DBP ≥90 mmHg；
  • With any diseases or conditions prior to enrollment that affected drug absorption, or patients could not take drugs orally;
  • Drugs containing St John's wort taken within 3 weeks prior to the first study treatment, or other strong inducers with CYP3A4 or strong inhibitors taken within two weeks prior to the first study treatment;
  • Have a gastrointestinal disease or condition that investigators suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis and other digestive disease, gastrointestinal tumor with active bleeding, or other gastrointestinal conditions that may cause bleeding or perforation, according to the investigator's judgement；
  • Patients with evidence or history of obvious bleeding tendency within 3 months before enrollment (>30 ml within 3 months, appeared hematemesis, black dung, hematochezia ) or Hemoptysis (>5 mL of fresh blood within 4 weeks) or a thromboembolic event (including stroke and/or transient ischemic attacks) within 12 months;
  • Have 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; congestive heart failure according to the New York Heart Association (NYHA) classification ≥ 2; ventricular arrhythmias which needs drug treatment; or left ventricular ejection fraction (LVEF) <50%;
  • Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）;
  • History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/m); or liver cirrhosis;
  • Mean corrected QT interval (QTc) ≥ 480 msec;
  • Occurrence of central nervous system metastatic or known brain metastatic;
  • Adverse events (AEs) due to previous anti-tumor therapy has not recovered to Common Terminology Criteria for Adverse Event (CTCAE) ≤Grade 1. Alopecia, lymphocytopenia, and grade ≤2 neurotoxicity due to oxaliplatin are not included;
  • Women who are pregnant or lactating;
  • With blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment;
  • Brachytherapy (i.e., implantation of radioactive seeds) within 60 days before enrollment;
  • Urine routine indicates urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g;
  • Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions which, according to judgement of the investigator, renders the patient inappropriate for using the investigational product or affect interpretation of study results.

Trial locations and contacts

1 site in 1 country.

shiping jiao, PhD contact

17368691876

jiaoshp@tcrximmune.cn

Wenbo Du, PhD contact

du-wenbo@qq.com

China1 site, 1 recruiting

  • Nanjing Drum tower hospital

    Nanjing, Jiangsu, 210009

    beicheng Sun, Phd, +8613776413940, sunbc@nju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Single-cell Analysis Reveals Surufatinib Mono-therapeutic Efficacy for Second-line Patients With Advanced Hepatocellular Carcinoma: a Single Arm, Open-label, Single Center, Prospective Study

This is a single-arm, single-center, open-label phase II study designed to assess the efficacy of surufatinib in participants with advanced hepatocellular carcinoma based on single-cell sequencing of tumor samples.

Read the detailed description

This is a single-arm, single-center, open-label phase II study designed to assess the efficacy of surufatinib in participants with advanced hepatocellular carcinoma based on single-cell sequencing of tumor samples. The primary outcome measure of the study is the regulation of immune microenvironment in hepatocellular carcinoma, included the proportion of tumor cells, vascular endothelial cells, and various immune cell clusters (including monocytes, macrophages, mast cells, T cells, B cells, dendritic cells, and neutrophils) in tumor samples before and after treatment with surufatinib, and the expression of related genes. Secondary Efficacy Endpoints include Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), 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.

Being tested
Surufatinib
Keywords
Surufatinib, single-cell sequencing
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • SurufatinibDrug

    Also called HMPL-012

    Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle

Study groups in NCT05171439
Study groupRoleWhat they receive
SurufatinibExperimentalAll subjects will receive study treatment in 28-day cycle, Surufatinib 300mg, orally, QD , the treatment will continue until one of the following conditions occurs: progression of disease, death, intolerable toxicity, or the end of study treatment (as other criteria specified in the protocol are met), whichever occurs first.
Receives: Drug: Surufatinib

What is being measured

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

  1. Bioinformatics analysis of single-cell sequencing in hepatocellular carcinoma

    Analysis of HCC molecular biology information using single cell sequencing technology.

    Measured: approximately 1 years

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    A duration from the date of initial treatment to disease progression or death of any cause.

    Measured: approximately 1 years

  2. Objective response rate (ORR)

    Rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.

    Measured: approximately 1 years

  3. Disease control rate (DCR)

    Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

    Measured: approximately 1 years

  4. adverse events(AE)

    adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

    Measured: approximately 1 years

Timeline

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

  1. First posted29 Dec 2021
  2. Study start1 Mar 2022
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Mar 2023 (estimated)

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
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171439
Sponsor's protocol ID
HMPL-012-SPRING-H104
Status last verified
Apr 2022
First submitted
7 Dec 2021
Last updated
14 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib in people with Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 11 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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?

Contact shiping jiao, PhD (17368691876, jiaoshp@tcrximmune.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioinformatics analysis of single-cell sequencing in hepatocellular carcinoma (time frame: approximately 1 years). 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 NCT05171439.

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 Apr 2022.

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