Hepatocellular CarcinomaPhase 2NCT06285019
Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma
A Phase 2 study testing TOMOX-HAIC, Sintilimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced 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?
- TOMOX-HAIC, Sintilimab and Bevacizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent/assent for the trial.
- Males or unpregnant females who age ≥ 18 years, ≤75 years.
- The investigator believes the patient is capable of complying with the study protocol.
- Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma.
- is not a candidate for radical surgery
- not received previous systemic treatment
Show all 9Show fewer
- patients must have at least one measurable lesion (RECIST 1.1)
- ECOG PS：0-1, 14 days before enrollment
- Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment
Who cannot join
- Prior history of other malignant tumors
- Current or prior immunodeficiency disorders or autoimmune diseases
- Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding
- Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study
- Conditions considered unsuitable for inclusion by researchers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200062
Lu Wang, M.D., +86-18121299357, w.lr@hotmail.com
About this study
Official title: Efficacy and Safety of Modified Hepatic Artery Infusion Chemotherapy (TOMOX-HAIC) in Combination With Sintilimab and Bevacizumab Biosimilar for the First-line Treatment of Advanced Hepatocellular Carcinoma: a Prospective, Single-arm, Phase II Clinical Study
This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide.The IMbrave150 study and the Orient-32 study demonstrated that PD-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma. In addition, HAIC combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy. Oxaliplatin-based FOLFOX regimen is currently the mainstream HAIC chemotherapy regimen (FOLFOX HAIC) in China.
The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma. Also, TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience, quality of life, and adherence while ensuring the efficacy.
In this clinical trial, patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar. The primary endpoint is overall response rate. The secondary endpoint are disease control rate, time to progression, duration of response, overall survival, and safety
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TOMOX-HAIC, Sintilimab, Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOMOX-HAICProcedure or surgery
Oxaliplatin 85mg/m^2 plus Raltitrexed 3mg/m^2, 21 days for a cycle
SintilimabDrug
200mg, ivgtt, d1, 21 days for a cycle
BevacizumabDrug
7.5mg/kg, ivgtt, d1, 21 days for a cycle
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar Receives: Procedure: TOMOX-HAIC; Drug: Sintilimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. and mRECIST
Measured: 24 months
Secondary outcomes (6)
disease control rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 and mRECIST as assessed by investigator
Measured: 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and mRECIST as assessed by investigator
Measured: 24 months
Time to progression (TTP)
the time from randomization until first evidence of disease progression
Measured: 24 months
Duration of response (DOR)
defined as the time from randomization to disease progression or death in patients who achieve complete or partial response
Measured: 24 months
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Measured: 24 months
adverse event (AE)
using the The NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285019
- Sponsor's protocol ID
- GWK-2023-004
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Modified Hepatic Artery Infusion Chemotherapy (TOMOX-HAIC) in Combination With Sintilimab and Bevacizumab Biosimilar for the First-line Treatment of Advanced Hepatocellular Carcinoma: a Prospective, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06285019
- Acronym / sponsor ID
- GWK-2023-004
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Feb 2024 (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 a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.
Detailed description
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide.The IMbrave150 study and the Orient-32 study demonstrated that PD-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma. In addition, HAIC combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy. Oxaliplatin-based FOLFOX regimen is currently the mainstream HAIC chemotherapy regimen (FOLFOX HAIC) in China.
The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma. Also, TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience, quality of life, and adherence while ensuring the efficacy.
In this clinical trial, patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar. The primary endpoint is overall response rate. The secondary endpoint are disease control rate, time to progression, duration of response, overall survival, and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Procedure: TOMOX-HAIC, Drug: Sintilimab, Drug: BevacizumabTOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be willing and able to provide written informed consent/assent for the trial.
- Males or unpregnant females who age ≥ 18 years, ≤75 years.
- The investigator believes the patient is capable of complying with the study protocol.
- Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma.
- is not a candidate for radical surgery
Key exclusion criteria (5 listed)
- Prior history of other malignant tumors
- Current or prior immunodeficiency disorders or autoimmune diseases
- Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding
- Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study
- Conditions considered unsuitable for inclusion by researchers
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 |
|---|---|---|
| TOMOX-HAICOxaliplatin 85mg/m^2 plus Raltitrexed 3mg/m^2, 21 days for a cycle | Procedure or surgery | Combination therapy |
| Sintilimab200mg, ivgtt, d1, 21 days for a cycle | Drug | Combination therapy |
| Bevacizumab7.5mg/kg, ivgtt, d1, 21 days for a cycle | Drug | Combination therapy |
Primary outcome
objective response rate (ORR)
Time frame: 24 months
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. and mRECIST
6 secondary outcomes
disease control rate (DCR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Time to progression (TTP)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
overall survival (OS)
Time frame: 24 months
adverse event (AE)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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 2 study testing TOMOX-HAIC, Sintilimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Fudan 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 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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 Lu Wang (+86-18121299357, cms024mm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: 24 months). 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 29 Feb 2024.