HCCPhase 3DaDaLiNCT04682210
Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection
A Phase 3 study testing Sintilimab and Bevacizumab in people with HCC and Adjuvant Therapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC, Adjuvant Therapy, Immunotherapy
- What is being tested?
- Sintilimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Dec 2024
- 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
- Patients with a first diagnosis of HCC who have undergone a curative resection
- Radiologic evidence of disease free ≥4 weeks after complete surgical resection
- Full recovery from surgical resection or post-operative transarterial chemoembolization before randomization
- Randomization needs to occur within 12 weeks of the date of surgical resection
- High risk for HCC recurrence as protocol defined
- Child-Pugh Score, Class A
Show all 9Show fewer
- ECOG performance status 0 or 1
- No prior systemic anticancer therapy for HCC
- Adequate hematologic and organ function
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of residual, recurrent, or metastatic disease at randomization
- History of hepatic encephalopathy or organ transplantation
- Patients who are in the waiting list for liver transplantation
- Patients with Vp4 portal vein thrombosis
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Open-lable, Multi Center Study of Sintilimab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Curative Hepatic Resection
This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection
Read the detailed description
There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.
- Conditions
- HCC, Adjuvant Therapy, Immunotherapy
- Being tested
- Sintilimab, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called Tyvyt
Sintilimab 200mg IV Q3W
BevacizumabDrug
Also called Byvasda
Bevacizumab 7.5mg/kg IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W Receives: Drug: Sintilimab; Drug: Bevacizumab |
| Arm B | No intervention | Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival (RFS)
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first).
Measured: up to 36 months after randomization
Secondary outcomes (5)
Overall Survival (OS）
OS is defined as the time from the date of randomisation until death due to any cause
Measured: up to 48 months after randomization
RFS Rate at 12 and 24 months
RFS rate defined as the proportion of patients without recurrence or death from any cause at 12 and 24 months after randomization.
Measured: at 12 and 24 months after randomization
OS Rate at 24 and 36 Months
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
Measured: at 24 and 36 months after randomization
TTR(time to recurrence)
TTR is defined as the time the date of randomisation until first documented disease recurrence.
Measured: up to 36 months after randomization
Adverse Events (AEs)
The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v5.0 from the date of randomization to 90 days after last dose of study treatment.
Measured: up to 48 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Min-Shan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682210
- Sponsor's protocol ID
- B2020-280-01
- Acronym
- DaDaLi
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-lable, Multi Center Study of Sintilimab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Curative Hepatic Resection
- ClinicalTrials.gov ID
- NCT04682210
- Acronym / sponsor ID
- DaDaLi / B2020-280-01
- Conditions
- HCC, Adjuvant Therapy, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 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.
This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection
Detailed description
There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Sintilimab, Drug: Bevacizumabsintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W |
| Arm B | No intervention | –Active surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a first diagnosis of HCC who have undergone a curative resection
- Radiologic evidence of disease free ≥4 weeks after complete surgical resection
- Full recovery from surgical resection or post-operative transarterial chemoembolization before randomization
- Randomization needs to occur within 12 weeks of the date of surgical resection
- High risk for HCC recurrence as protocol defined
Key exclusion criteria (7 listed)
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of residual, recurrent, or metastatic disease at randomization
- History of hepatic encephalopathy or organ transplantation
- Patients who are in the waiting list for liver transplantation
- Patients with Vp4 portal vein thrombosis
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 |
|---|---|---|
| SintilimabAlso: TyvytSintilimab 200mg IV Q3W | Drug | Arm A |
| BevacizumabAlso: ByvasdaBevacizumab 7.5mg/kg IV Q3W | Drug | Arm A |
Primary outcome
Recurrence-free Survival (RFS)
Time frame: up to 36 months after randomization
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first).
5 secondary outcomes
Overall Survival (OS）
Time frame: up to 48 months after randomization
RFS Rate at 12 and 24 months
Time frame: at 12 and 24 months after randomization
OS Rate at 24 and 36 Months
Time frame: at 24 and 36 months after randomization
TTR(time to recurrence)
Time frame: up to 36 months after randomization
Adverse Events (AEs)
Time frame: up to 48 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sintilimab and Bevacizumab in people with HCC and Adjuvant Therapy, run by Sun Yat-sen University 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 9 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 23 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongguo Zhou (020-87343585, 54757370@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (RFS) (time frame: up to 36 months after randomization). 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 23 Dec 2020.