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Trial Title:
HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC
NCT ID:
NCT06364007
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
HAIC
uHCC
immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HAIC+STRIDE+Len
Description:
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).
Arm group label:
Treating with a Designed Protocol
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 ~ 70 years old (including 70 years old), male and female;
2. Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by
histology / cytology ;
3. Patients with unresectable or metastatic hepatocellular carcinoma;
4. No systematic treatment. Patients recieved previously systematic treatment and
progressed can also be included in the group;
5. Patients who underwent hepatectomy in the past should be R0 resection, and the tumor
recurrence should be more than 6 months after operation;
6. At least one assessable lesion (mRECIST criteria);
7. Expected survival time ≥ 3 months;
8. ECOG 0 ~ 1;
9. Child Pugh ≤ 7;
10. Be able to cooperate to observe adverse events;
11. 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。
Exclusion Criteria:
1. History of symptomatic congestive heart failure, unstable angina pectoris,
2. Uncontrolled cardia arrhythmia
3. History of hepatic encephalopathy
4. Uncontrolled arterial hypertension
5. Co-infection with HBV and HDV
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Chuang Peng, PhD
Phone:
15200850489
Email:
pengchuangcn@163.com
Start date:
March 3, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Sulai Liu
Agency class:
Other
Source:
Hunan Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06364007
