HCCPhase 1NCT06463444
Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models
A Phase 1 study testing HAIC + Tislelizumab +lenvatinib in people with HCC and Precision Therapy, run by Chen Xiaoping at 1 site in China.
Trial summary
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC, Precision Therapy
- What is being tested?
- HAIC + Tislelizumab +lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Jun 2026
- 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 18-75.
- No previous local or systemic treatment for hepatocellular carcinoma.
- Child-Pugh liver function score ≤ 7.
- ECOG PS 0-1.
- No serious organic diseases of the heart, lungs, brain, kidneys, etc.
- Enhanced MRI determines that the tumor is technically unresectable.
- Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy.
- Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors.
Who cannot join
- Pregnant and lactating women.
- Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
- A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
- Active infection.
- Other significant clinical and laboratory abnormalities that affect the safety evaluation.
- Inability to follow the study protocol for treatment or follow up as scheduled.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
WanGuang Zhang, 13886195965, wgzhang@tjh.tjmu.edu.cn
About this study
Official title: Precision Treatment of Unresectable Liver Cancer Based on Multi-omics Deep Learning Model: a Multi-center Prospective Single-arm Study
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 monoclonal antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%.
Read the detailed description
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%. However, the selection of patients who will benefit from the therapy remains a major challenge for the individualized treatment of HCC, which requires more accurate prediction of combination therapy.
With the advancement of sequencing technology, more and more fine-grained biological data can be obtained, including radiomics, pathology, genomics and immunomics. In recent years, the development of new methods such as graph neural network and multi-scale PHATE makes it possible to integrate multi-omics data. The use of artificial intelligence models to integrate multimodal data is an effective means to predict treatment response more accurately, which is helpful for more accurate and detailed classification of patients with different treatment outcomes, and to explore the internal mechanism of treatment response or not.
We constructed a multi-omics deep learning prediction model based on the retrospective cohort data from multiple medical centers (who received HAIC combined with target therapy and immunotherapy). The model could better distinguish the patients who would benefit from combination therapy, with an AUC of 0.86.
Therefore, the investigators conducted this multicenter, prospective, single-arm study to explore the response and prognosis of combination therapy in a population screened by the model and to evaluate the predictive power of the model.
- Conditions
- HCC, Precision Therapy
- Being tested
- HAIC + Tislelizumab +lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC + Tislelizumab +lenvatinibDrug
All patients were treated with HAIC combined with tislelizumab and lenvatinib.
- HAIC was adopted of the FOFOLX 6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days.
- Lenvatinib was started before HAIC treatment, discontinued during HAIC treatment, Oral 8 mg or 12mg once a day depending body weight.
- First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later.
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy group | Experimental | All patients received HAIC combined with targeted therapy and immunotherapy Receives: Drug: HAIC + Tislelizumab +lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate(ORR) was defined as the sum of cases with complete response (CR) and partial response (PR) which assessed by the mRESIST criteria.
Measured: From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 months.
Secondary outcomes (2)
Overall survival
OS is defined as the time from enrollment to death from any cause.
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months.
Safety Assessment
Any adverse event during treatment that is incompatible with the therapeutic purpose of the medication.The incidence and severity of adverse events and serious adverse events as assessed by CTCAE v5.0.
Measured: Baseline up to study termination, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaoping, Tongji Hospital
- Investigators
- WanGuang Zhang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463444
- Sponsor's protocol ID
- Precision01
- Status last verified
- Jun 2024
- First submitted
- 19 May 2024
- Last updated
- 17 Jun 2024
- 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 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Treatment of Unresectable Liver Cancer Based on Multi-omics Deep Learning Model: a Multi-center Prospective Single-arm Study
- ClinicalTrials.gov ID
- NCT06463444
- Acronym / sponsor ID
- Precision01
- Conditions
- HCC, Precision Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chen XiaopingUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Jun 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.
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 monoclonal antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%.
Detailed description
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%. However, the selection of patients who will benefit from the therapy remains a major challenge for the individualized treatment of HCC, which requires more accurate prediction of combination therapy.
With the advancement of sequencing technology, more and more fine-grained biological data can be obtained, including radiomics, pathology, genomics and immunomics. In recent years, the development of new methods such as graph neural network and multi-scale PHATE makes it possible to integrate multi-omics data. The use of artificial intelligence models to integrate multimodal data is an effective means to predict treatment response more accurately, which is helpful for more accurate and detailed classification of patients with different treatment outcomes, and to explore the internal mechanism of treatment response or not.
We constructed a multi-omics deep learning prediction model based on the retrospective cohort data from multiple medical centers (who received HAIC combined with target therapy and immunotherapy). The model could better distinguish the patients who would benefit from combination therapy, with an AUC of 0.86.
Therefore, the investigators conducted this multicenter, prospective, single-arm study to explore the response and prognosis of combination therapy in a population screened by the model and to evaluate the predictive power of the model.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined therapy group | Experimental | Drug: HAIC + Tislelizumab +lenvatinibAll patients received HAIC combined with targeted therapy and immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-75.
- No previous local or systemic treatment for hepatocellular carcinoma.
- Child-Pugh liver function score ≤ 7.
- ECOG PS 0-1.
- No serious organic diseases of the heart, lungs, brain, kidneys, etc.
Key exclusion criteria (6 listed)
- Pregnant and lactating women.
- Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
- A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
- Active infection.
- Other significant clinical and laboratory abnormalities that affect the safety evaluation.
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 |
|---|---|---|
| HAIC + Tislelizumab +lenvatinibAll patients were treated with HAIC combined with tislelizumab and lenvatinib. 1. HAIC was adopted of the FOFOLX 6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days. 2. Lenvatinib was started before HAIC treatment, discontinued during HAIC treatment, Oral 8 mg or 12mg once a day depending body weight. 3. First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later. | Drug | Combined therapy group |
Primary outcome
Objective response rate
Time frame: From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 months.
Objective response rate(ORR) was defined as the sum of cases with complete response (CR) and partial response (PR) which assessed by the mRESIST criteria.
2 secondary outcomes
Overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months.
Safety Assessment
Time frame: Baseline up to study termination, assessed up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- 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.
WanGuang Zhang principal investigator
Tongji Hospital
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 HAIC + Tislelizumab +lenvatinib in people with HCC and Precision Therapy, run by Chen Xiaoping 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 8 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: status not confirmed, as of the sponsor's last update on 17 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WanGuang Zhang (13886195965, wgzhang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 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 17 Jun 2024.