AzTrials
AzTrials

Hepatocellular CarcinomaPhase 3NCT05564338

Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Participants With Hepatocellular Carcinoma

A Phase 3 study testing Sitravatinib and Tislelizumab in people with Hepatocellular Carcinoma, run by BeiGene.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo. The study will also compare the recurrence-free survival (RFS) in participants with hepatocellular carcinoma (HCC) who are at high risk of recurrence after surgical resection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sitravatinib and Tislelizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jun 2023to 30 Apr 2028
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant with a first diagnosis of HCC must have undergone a curative-intent resection within 4 to 12 weeks before randomization and have a documented histological confirmation of HCC diagnosis and negative surgical margins (R0 resection) of the resected tumor
  • Participant must have tumor-free status as assessed by the investigator and have fully recovered from surgical resection before randomization
  • Participant must have no extrahepatic HCC
  • ECOG Performance Status ≤ 1
  • Participant who has undergone surgical resection and is defined as having a high risk of HCC recurrence

Who cannot join

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  • Evidence of residual, recurrent, or metastatic disease of HCC before randomization
  • Major macrovascular (gross vascular) invasion of the portal vein (Vp3 or Vp4) or any grade of macrovascular invasion in the hepatic vein or inferior vena cava
  • Untreated chronic hepatitis B (HBV) or chronic HBV carriers with HBV DNA ≥ 2000 IU/mL at Screening
  • Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Compare the Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Surgical Resection

The purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo. The study will also compare the recurrence-free survival (RFS) in participants with hepatocellular carcinoma (HCC) who are at high risk of recurrence after surgical resection.

Being tested
Sitravatinib, Tislelizumab, sitravatinib-matching placebo, tislelizumab-matching placebo
Keywords
hepatocellular carcinoma, sitravatinib, tislelizumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • SitravatinibDrug

    Administered orally

  • TislelizumabDrug

    Administered intravenously

  • sitravatinib-matching placeboDrug

    administered orally

  • tislelizumab-matching placeboDrug

    administered intravenously

Study groups in NCT05564338
Study groupRoleWhat they receive
Treatment Arm A: sitravatinib + tislelizumabExperimentalsitravatinib once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years)
Receives: Drug: Sitravatinib; Drug: Tislelizumab
Treatment Arm B: Placebo + tislelizumabExperimentalsitravatinib-matching placebo once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years)
Receives: Drug: Tislelizumab; Drug: sitravatinib-matching placebo
Treatment Arm C:Sitravatinib + PlaceboExperimentalsitravatinib once daily and tislelizumab-matching placebo once every 6 weeks, for up to 17 cycles (approximately 2 years)
Receives: Drug: Sitravatinib; Drug: tislelizumab-matching placebo
Treatment Arm D: Matching PlaceboExperimentalsitravatinib-matching placebo once daily and tislelizumab-matching placebo once every 6 weeks, for up to 17 cycles (approximately 2 years)
Receives: Drug: sitravatinib-matching placebo; Drug: tislelizumab-matching placebo

What is being measured

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

  1. Recurrence-free survival (RFS) as assessed by the investigator between Arm A and Arm D

    RFS is defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma (HCC) as assessed by the investigator, or death from any cause, whichever occurs first.

    Measured: Up to 2 Years

  2. Recurrence-free survival (RFS) as assessed by the investigator between Arm B and Arm D

    defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first.

    Measured: Up to 2 Years

Secondary outcomes (12)

  1. Arm A and Arm B: Recurrence-free survival (RFS)

    defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first.

    Measured: Up to 2 Years

  2. Arm A and Arm C: Recurrence-free survival (RFS)

    defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first.

    Measured: Up to 2 Years

  3. Arm A and Arm D: overall survival (OS)

    defined as the time from the date of randomization until the date of death due to any cause

    Measured: Up to 5 Years

  4. Arm B and Arm D: overall survival (OS)

    defined as the time from the date of randomization until the date of death due to any cause

    Measured: Up to 5 Years

  5. Arm A and Arm B: overall survival (OS)

    defined as the time from the date of randomization until the date of death due to any cause

    Measured: Up to 5 Years

  6. Arm A and Arm C: overall survival (OS)

    defined as the time from the date of randomization until the date of death due to any cause

    Measured: Up to 5 Years

  7. Arm A and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator

    defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC

    Measured: Up to 2 Years

  8. Arm B and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator

    defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC

    Measured: Up to 2 Years

  9. Arm A and Arm B: time to extrahepatic spread (EHS) as assessed by the investigator

    defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC

    Measured: Up to 2 Years

  10. Arm A and Arm C: time to extrahepatic spread (EHS) as assessed by the investigator

    defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC

    Measured: Up to 2 Years

  11. Number of participants with adverse events (AEs)

    Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0, vital signs, and clinical laboratory test results in the Safety Analysis Set

    Measured: Up to 5 Years

  12. Participants Reported Outcome as measured at Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its hepatocellular carcinoma cancer module QLQ-HCC18

    Quality of Life change with treatment. Scale scores are calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100

    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 posted3 Oct 2022
  2. Study start30 Jun 2023 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Why it stopped: Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern or the request from any health authority worldwide.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05564338
Sponsor's protocol ID
BGB-A317-Sitravatinib-303
Status last verified
Jun 2023
First submitted
29 Sep 2022
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitravatinib and Tislelizumab in people with Hepatocellular Carcinoma, run by BeiGene.

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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 7 Jun 2023. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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?

Recurrence-free survival (RFS) as assessed by the investigator between Arm A and Arm D (time frame: Up to 2 Years). The study lists 2 primary outcomes in all. 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 NCT05564338.

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 7 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in