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Hepatocellular Carcinoma With Portal Vein Tumor ThrombusPhase 2NCT04850157

Tislelizumab Combined With IMRT Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT

A Phase 2 study testing Tislelizumab and IMRT in people with Hepatocellular Carcinoma With Portal Vein Tumor Thrombus, run by Shanghai Zhongshan Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Due to the biological characteristics and liver anatomical characteristics of liver cancer, liver cancer cells easily invade the vascular system, especially the portal venous system, forming portal vein tumor thrombus (PVTT) , and its incidence is reported to be 44.0% ~ 62.2%. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tislelizumab and IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
20 Apr 2021to 20 Dec 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

  • Histologically or cytologically confirmed hepatocellular carcinoma
  • Patients with at least one measurable lesion
  • Resectable primary lesion, PVTTⅡ-Ⅲtype
  • No previous treatment for hepatocellular carcinoma
  • Eastern Cooperative Oncology Group(ECOG): Performance Status(PS)score 0-1
  • Child-Pugh score A
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  • Expected survival ≥ 3 months
  • Baseline blood routine and blood biochemical indicators should meet the following criteria:
  • hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.5 × 10 ^/L, platelet count ≥ 75 × 10 ^/L aspartate or alanine aminotransferase 5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the ULN, serum albumin ≥ 30 g/L; serum creatinine 1.5 times the ULN; international normalized ratio (INR)) ≤ 2 or prothrombin time (PT) more than the upper limit of normal range ≤ 6 seconds
  • Appropriate to participate in this trial as assessed by the investigator before entering the study
  • Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study
  • Signed informed consent.

Who cannot join

  • Imaging showed distant metastasis
  • Previous treatment with other effective regimens (including surgery, radiotherapy, systemic therapy, etc.)
  • Previous allergic reactions to the same kind of drugs
  • Pregnant or lactating patients
  • Active hepatitis B or C (hepatitis B: HBsAg positive and Hepatitis B (HBV )DNA ≥ 1*10^4 IU/ml; hepatitis C: hepatitis C virus (HCV) antibody and HCV RNA positive, requiring simultaneous antiviral therapy)
  • Pericardial effusion, uncontrolled pleural effusion or clinically severe ascites at screening
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  • History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease
  • Suffering from severe cardiovascular disease within 12 months before screening, such as symptomatic coronary heart disease,≥II congestive heart failure, uncontrolled arrhythmia, infarction, etc
  • Any active immunodeficiency or autoimmune disease at screening and/or any history of immunodeficiency or autoimmune disease that may recur (such as hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc.)
  • Use of steroids or other systemic immunosuppressive therapy 14 days before enrollment; use of steroids or other systemic immunosuppressive therapy
  • Patients with other previous malignancies that are not cured; Patients with other previous malignancies that are not cured
  • Immunocompromised patients, such as immunocompromised patients, such as human immunodeficiency virus (HIV) positive; positive
  • With uncontrollable psychosis; With uncontrollable psychosis
  • Other factors make the investigators think it is inappropriate to participate in this trial.

Trial locations and contacts

1 site in 1 country.

Xinrong Yang contact

86-13764295279

yang.xinrong@zs-hospital.sh.cn

China1 site

  • Zhongshan hospital, Fudan University

    Shanghai

    Xinrong Yang, yang.xinrong@zs-hospital.sh.cn

    Jian Zhou

Other trials in China

About this study

Official title: Tislelizumab Combined With Intensity Modulated Radiation Therapy（IMRT) Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Due to the biological characteristics and liver anatomical characteristics of liver cancer, liver cancer cells easily invade the vascular system, especially the portal venous system, forming portal vein tumor thrombus (PVTT) , and its incidence is reported to be 44.0% ~ 62.2%. Once PVTT occurs in patients with liver cancer, the disease develops rapidly, and intrahepatic and extrahepatic metastasis, portal hypertension, jaundice, and abdominal effusion can occur in a short time with an average survival time of 2.7 months. PVTT is one of the major adverse factors for the prognosis of liver cancer and occupies an important weight influence in the clinical staging system of liver cancer. In some hepatocellular carcinoma (HCC) patients with PVTT and selective resectability, surgery versus non-surgery can lead to better survival of patients.

A retrospective analysis showed that neoadjuvant radiotherapy can reduce the extent of invasion of PVTT and improve postoperative survival in some HCC patients. Another prospective study showed that neoadjuvant radiotherapy could significantly improve the overall survival of resectable liver cancer with PVTT, and neoadjuvant radiotherapy could improve the 2-year survival of patients from 9.4% to 27.4% 27.4%, with an effective response of 20.7%.

This study is a prospective, single-center, single-arm study to assess the efficacy and safety of neoadjuvant therapy with tislelizumab combined with IMRT for resectable liver cancer with PVTT.

Being tested
Tislelizumab, IMRT

What participants receive

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

Study groups in NCT04850157
Study groupRoleWhat they receive
Tislelizumab+IMRTExperimentalNot described
Receives: Drug: Tislelizumab; Radiation: IMRT

What is being measured

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

  1. Relapse-free survival( RFS)

    Defined as the time from the date of surgery to the date of disease recurrence or death whichever occur first

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Resection rate (R0 resection rate)

    Defined as the proportion of patients undergoing radical resection to the total subjects (R0 resection rate)

    Measured: Up to 2 years

  2. Objective response rate (ORR) assessed by mRECIST

    Defined as the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

    Measured: Up to 2 years

  3. Overall survival (OS)

    Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive

    Measured: Up to 2 years

  4. Adverse Events (AEs)

    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; Surgical safety including Intraoperative blood loss，PHLF assessed by ISGLS（2012），Postoperative complications evaluated by modified Clavien-Dindo system.

    Measured: Up to 2 years

Timeline

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

  1. First posted20 Apr 2021
  2. Study start20 Apr 2021 (estimated)
  3. Primary completion20 Apr 2022 (estimated)
  4. Study completion20 Dec 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04850157
Sponsor's protocol ID
B2020-187R-1
Status last verified
Apr 2021
First submitted
12 Apr 2021
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and IMRT in people with Hepatocellular Carcinoma With Portal Vein Tumor Thrombus, run by Shanghai Zhongshan 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 12 inclusion and 14 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 20 Apr 2021. 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 Xinrong Yang (86-13764295279, yang.xinrong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival( RFS) (time frame: Up to 2 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 NCT04850157.

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 20 Apr 2021.

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