Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with hepatocellular carcinoma with PVTT can benefit from surgical resection and radiotherapy. As the rapid development of systematic treatment in hepatocellular carcinoma, ICIs neoadjuvant therapy is being actively explored .But there is no evidence to prove the safety and efficacy of lenvatinib and anti-PD1 antibody combined with radiotherapy neoadjuvant treatment for resectable hepatocellular carcinoma with PVTT. This study intends to supplement the evidence of benefit in such patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab+Lenvatinib+Radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab will be at a dose of 200mg,Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety(CTCAE v5.0) | Number of patients who reported incidence of grade ≥3 treatment related adverse events. | up to 5 years |
| Number of patients who complete pre-op treatment and proceed to surgery | Number of patients who complete pre-op treatment and proceed to surgery | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response(MPR) | Survival tumor ≤10% during surgery | Within 3 months after surgery |
| Objective Response Rate(ORR) | Efficacy included objective response (includes complete and partial response) according to modified RECIST 1.1 for HCC |
Not provided
Inclusion Criteria:
Aged 18-70, with no gender limitation;
HCC patients who strictly met the clinical diagnostic criteria of The Code for The Diagnosis and Treatment of Primary Liver Cancer (2019 edition) or were confirmed by histopathological or cytological examination;
BCLC stage C, no distant metastasis;
Patients with PVTT of type VP1-2-3-4 according to Japanese VP Classification;
The primary tumor can be resected (the remaining liver has complete vascular structure and sufficient liver volume, in line with the decision-making system of safe liver resection)
ECOG score 0-1;
Child-Pugh score ≤7;
If the patient is HBV antigen positive, HBV DNA < 500 IU/ mL, conventional antiviral treatment;
The major organs meeting the following criteria:
Adequate control of blood pressure (BP) with up to 3 antihypertensive drugs, defined as BP-lt at screening time; = 150/90 mmHg (mmHg), and there was no change in antihypertensive therapy 1 week prior to cycle 1 / day 1.
Patients are expected to survive longer than 3 months.
No pregnancy or pregnancy plan.
Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiahong Dong, MD | Contact | 17346539401 | ysza02008@btch.edu.cn | |
| ShiZhong Yang | Contact | 17346539401 | ysza02008@btch.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | Beijing Municipality | 102218 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36505833 | Derived | Li G, Shu B, Zheng Z, Yin H, Zhang C, Xiao Y, Yang Y, Yan Z, Zhang X, Yang S, Li G, Dong J. Safety and efficacy of radiotherapy combined with lenvatinib plus PD-1 inhibitors as neo-adjuvant therapy in hepatocellular carcinoma with portal vein thrombus: protocol of an open-label, single-arm, prospective, multi-center phase I trial. Front Oncol. 2022 Nov 24;12:1051916. doi: 10.3389/fonc.2022.1051916. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lenvatinib |
| Drug |
On the first day of the trial, Lenvatinib will be taken orally once daily (8mg/day ≤ 60kg or 12mg/day ≥60kg). |
|
| radiotherapy | Radiation | Radiotherapy will be completed within two weeks at a dose of 300cGy× 10 fraction |
|
| within 1 week before surgery |
| Imaging-pathology Concordance Rate | Imaging-pathology Concordance Rate | Within 3 months after surgery |
| PVTT regression rate | The fading rate of PVTT | Within 3 months after surgery |
| Median Overall survival(mOS) | mOS is defined as the median difference (in months) between the date of study enrollment to the date death due to any cause | up to 5 years |
| Recurrence free survival(RFS) | From radical resection to the date of the first documented tumor into recurrence or death from any cause, whichever occurred first | 1 year after surgery |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C531958 | lenvatinib |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided