Hepatocellular CarcinomaPhase 2NCT06364007
HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC
A Phase 2 study testing HAIC+STRIDE+Len in people with Hepatocellular Carcinoma, run by Sulai Liu at 1 site in China.
Trial summary
The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- HAIC+STRIDE+Len
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2024to 31 Mar 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 ~ 70 years old (including 70 years old), male and female;
- Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
- Patients with unresectable or metastatic hepatocellular carcinoma;
- No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
- Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
- At least one assessable lesion (mRECIST criteria);
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- Expected survival time ≥ 3 months;
- ECOG 0 ~ 1;
- Child Pugh ≤ 7;
- Be able to cooperate to observe adverse events;
- Major organs are functioning normally:
- Hemoglobin ≥ 90 g / L;
- ANC ≥ 1.5 × 109/L；
- Platelet count ≥ 75 × 109/L；
- Albumin ≥ 28 g / L;
- Total bilirubin ≤ 2 × ULN;
- AST, ALT ≤ 5 × ULN；
- ALP ≤ 5 × ULN；
- Creatinine ≤ 1.5 × ULN；
- INR or PT ≤ 1.5 × ULN； J) APTT ≤ 1.5 × ULN。
Who cannot join
- History of symptomatic congestive heart failure, unstable angina pectoris,
- Uncontrolled cardia arrhythmia
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Co-infection with HBV and HDV
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan
Chuang Peng, PhD, 15200850489, pengchuangcn@163.com
About this study
Official title: Phase II Study Evaluating the Efficacy of Tremelimumab (T) Plus Durvalumab (D) With Lenvatinib Combined With Concurrent Hepatic Arterial Infusion Chemotherapy (HAIC) in Patients (Pts) With Unresectable Hepatocellular Carcinoma (uHCC)
The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HAIC+STRIDE+Len
- Keywords
- HAIC, uHCC, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC+STRIDE+LenDrug
patients will be administrated with STRIDE plus lenvatinib (8 mg or 12 mg) once daily plus HAIC- modified FOLFOX (oxaliplatin, 85 mg/m2; leucovorin, 400 mg/m2; 5-fluorouracil bolus, 400 mg/m2 on day 1; 5-fluorouracil infusion, 2400 mg/m2 for 46 h).
| Study group | Role | What they receive |
|---|---|---|
| Treating with a Designed Protocol | Experimental | Not described Receives: Drug: HAIC+STRIDE+Len |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate
Measured: about 1 year
Secondary outcomes (4)
PFS
progression-free survival
Measured: about 1.5 year
OS
overall survival
Measured: about 3 year
DCR
disease control rate
Measured: about 1 year
AE
adverse events
Measured: about 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start3 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sulai Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sulai Liu, Hunan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364007
- Sponsor's protocol ID
- SLiu0401
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Efficacy of Tremelimumab (T) Plus Durvalumab (D) With Lenvatinib Combined With Concurrent Hepatic Arterial Infusion Chemotherapy (HAIC) in Patients (Pts) With Unresectable Hepatocellular Carcinoma (uHCC)
- ClinicalTrials.gov ID
- NCT06364007
- Acronym / sponsor ID
- SLiu0401
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HAIC, uHCC, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sulai LiuUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 12 Apr 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.
The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treating with a Designed Protocol | Experimental | Drug: HAIC+STRIDE+Len |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age 18 ~ 70 years old (including 70 years old), male and female;
- Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
- Patients with unresectable or metastatic hepatocellular carcinoma;
- No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
- Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
Key exclusion criteria (5 listed)
- History of symptomatic congestive heart failure, unstable angina pectoris,
- Uncontrolled cardia arrhythmia
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Co-infection with HBV and HDV
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+STRIDE+Lenpatients will be administrated with STRIDE plus lenvatinib (8 mg or 12 mg) once daily plus HAIC- modified FOLFOX (oxaliplatin, 85 mg/m2; leucovorin, 400 mg/m2; 5-fluorouracil bolus, 400 mg/m2 on day 1; 5-fluorouracil infusion, 2400 mg/m2 for 46 h). | Drug | Treating with a Designed Protocol |
Primary outcome
ORR
Time frame: about 1 year
objective response rate
4 secondary outcomes
PFS
Time frame: about 1.5 year
OS
Time frame: about 3 year
DCR
Time frame: about 1 year
AE
Time frame: about 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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 HAIC+STRIDE+Len in people with Hepatocellular Carcinoma, run by Sulai Liu 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 20 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 12 Apr 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 Chuang Peng, PhD (15200850489, pengchuangcn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: about 1 year). 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 12 Apr 2024.