Hepatocellular CarcinomaPhase 1NCT04635527
A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
A Phase 1 study testing IBI318 and cTACE in people with Hepatocellular Carcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- IBI318 and cTACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2020to 7 Mar 2023
- Phase
- Phase 1
- 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
- Aged ≥ 18 years and ≤ 75 years at the time of consent.
- Hepatocellular carcinoma confirmed by histology/cytology.
- Lesions with measurable disease at baseline by mRECIST.
- Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria.
- Child-Pugh: <=6
- Adequate organ and bone marrow function.
Who cannot join
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma.
- Potential liver transplant candidates
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
- With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- IBI318, cTACE, placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI318Drug
before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W
cTACEProcedure or surgery
conventional transarterial chemoembolization
placeboDrug
before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W
| Study group | Role | What they receive |
|---|---|---|
| IBI318 combined with conventional TACE (cTACE) | Experimental | Not described Receives: Drug: IBI318; Procedure: cTACE |
| Placebo combined with conventional TACE (cTACE) | Placebo comparator | Not described Receives: Procedure: cTACE; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing clinical and laboratory adverse events (AEs)
Measured: Up to 90 days post last dose
Secondary outcomes (6)
The percentage of subjects with pathological Complete Response (pCR) after liver resection
Measured: 3 years
The percentage of subjects with major pathological response (MPR) after liver resection
Measured: 3 years
The percentage of subjects with R0 resection
Measured: 3 years
Objective response rate (ORR) in two arms based on mRECIST by investigator
Measured: 3 years
Disease-free survival (DFS) in two arms based on mRECIST by investigator
Measured: 3 years
Overall survival (OS) in two arms
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start24 Dec 2020
- Primary completion27 Aug 2021
- Study completion7 Mar 2023
Why it stopped: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.
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.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635527
- Sponsor's protocol ID
- CIBI318F101
- Status last verified
- Mar 2023
- First submitted
- 13 Nov 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04635527
- Acronym / sponsor ID
- CIBI318F101
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 19 Nov 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.
The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI318 combined with conventional TACE (cTACE) | Experimental | Drug: IBI318, Procedure: cTACE |
| Placebo combined with conventional TACE (cTACE) | Placebo comparator | Procedure: cTACE, Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years and ≤ 75 years at the time of consent.
- Hepatocellular carcinoma confirmed by histology/cytology.
- Lesions with measurable disease at baseline by mRECIST.
- Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria.
- Child-Pugh: <=6
Key exclusion criteria (5 listed)
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma.
- Potential liver transplant candidates
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
- With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
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 |
|---|---|---|
| IBI318before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W | Drug | IBI318 combined with conventional TACE (cTACE) |
| cTACEconventional transarterial chemoembolization | Procedure or surgery | IBI318 combined with conventional TACE (cTACE), Placebo combined with conventional TACE (cTACE) |
| placebobefore surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W | Drug | Placebo combined with conventional TACE (cTACE) |
Primary outcome
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: Up to 90 days post last dose
6 secondary outcomes
The percentage of subjects with pathological Complete Response (pCR) after liver resection
Time frame: 3 years
The percentage of subjects with major pathological response (MPR) after liver resection
Time frame: 3 years
The percentage of subjects with R0 resection
Time frame: 3 years
Objective response rate (ORR) in two arms based on mRECIST by investigator
Time frame: 3 years
Disease-free survival (DFS) in two arms based on mRECIST by investigator
Time frame: 3 years
Overall survival (OS) in two arms
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI318 and cTACE in people with Hepatocellular Carcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Mar 2023. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.). Results are not available in the source record.
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?
Number of participants experiencing clinical and laboratory adverse events (AEs) (time frame: Up to 90 days post last dose). 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 16 Mar 2023.