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Status unknownNCT04850157Updated Apr 20, 2021

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

A Phase 2 interventional study of Tislelizumab and IMRT in Hepatocellular Carcinoma With Portal Vein Tumor Thrombus, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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%. 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.

02

Conditions studied

  • Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
03

In context

Carcinoma

6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 5,167 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 638 studies on the registry; 285 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Tislelizumab+IMRT

    Drug: Tislelizumab · Radiation: IMRT

Interventions

  • DrugTislelizumab

    200mg, Q3W

  • RadiationIMRT

    4 Gy\* 5 Fx,5Fx/Week

06

What researchers measure

Primary outcomes

  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

    Time frame: Up to 2 years

Secondary outcomes

  1. Resection rate (R0 resection rate)

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

    Time frame: 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).

    Time frame: 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

    Time frame: 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.

    Time frame: Up to 2 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04850157
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Apr 20, 2021
Start date
Apr 20, 2021 (estimated)
Primary completion
Apr 20, 2022 (estimated)
Completion
Dec 20, 2023 (estimated)
Last update
Apr 20, 2021

Study contacts

Xinrong Yang
Contact
yang.xinrong@zs-hospital.sh.cn
86-13764295279

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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