Hepatocellular CarcinomaPhase 2NCT04652492
Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma
A Phase 2 study testing Tislelizumab in combination with cTACE in people with Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Tislelizumab in combination with cTACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2020to Nov 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old on the day the patients voluntary to participate in the study and signing in ICF.
- Histological or clinical diagnosis of HCC.
- BCLC stage C patients ineligible for surgical resection or liver transplantation.
- No prior systemic therapy for HCC (including immunotherapy).
- Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
- Child-Pugh A-B7.
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- ECOG PS 0-1.
- Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR > 30 ml/min/1.73 m2)
- For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable.
- life expectancy of more than 3 months.
- Patients must be able to understand and willing to sign a written informed consent document.
- Patients suitable for TACE therapy assessed by investigators.
Who cannot join
- Tumor thrombus involving main trunk of portal vein or inferior vena cava.
- Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer.
- Disease history of grade 2 or more hepatic encephalopathy.
- Extrahepatic metastasis on baseline imaging.
- HIV infection or syphilis.
- Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents.
- Tumor diffuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
About this study
Official title: A Multicentric, Open-Label Study to Evaluate Tislelizumab in Combination With Transarterial Chemoembolization as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma
A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.
Read the detailed description
This is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(cTACE) as first-line treatment in BCLC stage C HCC patients without extrahepatic spread. The primary endpoint is time to progression (TTP).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Tislelizumab in combination with cTACE
- Keywords
- TACE, 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.
Tislelizumab in combination with cTACEDrug
Also called BGB-A317
On-demanded cTACE in combined with tislelizumab (200mg q3w ivgtt on day 4 of each 21-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab in combination with cTACE | Experimental | Tislelizumab in combination with on-demanded cTACE Receives: Drug: Tislelizumab in combination with cTACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTP assessed by independent review committee(IRC)
Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).
Measured: up to 24 months after enrollment or study close
Secondary outcomes (7)
TTP assessed by investigators
Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression, assessed by investigators per mRECIST.
Measured: An expected average of 8 months
PFS
Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST.
Measured: An expected average of 8 months
ORR
Defined as the proportion of patients with a documented CR or PR, assessed by IRC and investigators, respectively, per mRECIST.
Measured: An expected average of 8 months
DCR
Defined as the proportion of patients whose best overall response (BOR) is CR, PR, or SD, assessed by IRC and investigators, respectively, per mRECIST.
Measured: An expected average of 8 months
DOR
Defined as the time from the first confirmation of objective remission (CR or PR) to the first recording of disease progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST.
Measured: An expected average of 8 months
OS
Defined as the time from the treatment initiation to the date of death due to any cause.
Measured: An expected average of 24 months
Safety
NCI-CTCAE v5.0.
Measured: up to 24 months after enrollment or study close
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start27 Oct 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652492
- Sponsor's protocol ID
- BGB-A317-2004-IIT
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Open-Label Study to Evaluate Tislelizumab in Combination With Transarterial Chemoembolization as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04652492
- Acronym / sponsor ID
- BGB-A317-2004-IIT
- Conditions
- Hepatocellular Carcinoma
- Keywords
- TACE, tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.
Detailed description
This is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(cTACE) as first-line treatment in BCLC stage C HCC patients without extrahepatic spread. The primary endpoint is time to progression (TTP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab in combination with cTACE | Experimental | Drug: Tislelizumab in combination with cTACETislelizumab in combination with on-demanded cTACE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18-70 years old on the day the patients voluntary to participate in the study and signing in ICF.
- Histological or clinical diagnosis of HCC.
- BCLC stage C patients ineligible for surgical resection or liver transplantation.
- No prior systemic therapy for HCC (including immunotherapy).
- Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
Key exclusion criteria (7 listed)
- Tumor thrombus involving main trunk of portal vein or inferior vena cava.
- Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer.
- Disease history of grade 2 or more hepatic encephalopathy.
- Extrahepatic metastasis on baseline imaging.
- HIV infection or syphilis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab in combination with cTACEAlso: BGB-A317On-demanded cTACE in combined with tislelizumab (200mg q3w ivgtt on day 4 of each 21-day cycle) | Drug | Tislelizumab in combination with cTACE |
Primary outcome
TTP assessed by independent review committee(IRC)
Time frame: up to 24 months after enrollment or study close
Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).
7 secondary outcomes
TTP assessed by investigators
Time frame: An expected average of 8 months
PFS
Time frame: An expected average of 8 months
ORR
Time frame: An expected average of 8 months
DCR
Time frame: An expected average of 8 months
DOR
Time frame: An expected average of 8 months
OS
Time frame: An expected average of 24 months
Safety
Time frame: up to 24 months after enrollment or study close
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gao-Jun Teng, MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in combination with cTACE in people with Hepatocellular Carcinoma, run by Zhongda 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 7 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 3 Dec 2020. 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 Hai-Dong Zhu, MD (86-13851420979 ext. 86-25-83272121, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTP assessed by independent review committee(IRC) (time frame: up to 24 months after enrollment or study close). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2020.