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| Name | Class |
|---|---|
| Eastern Hepatobiliary Surgery Hospital | OTHER |
| Sun Yat-sen University | OTHER |
| West China Hospital | OTHER |
| Cancer Hospital of Guangxi Medical University |
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Patients with HCC with portal vein involvement not involving the bifurcation (vP1-vP3) and no evidence of extra-hepatic spread will be enrolled. Patients will be required to have Child's A liver function and no significant portal hypertension. Patients will be randomly assigned with a 1:1 ratio to either surgery followed by adjuvant sorafenib or sorafenib alone. Patients will be followed by serial imaging. The primary end-point is overall survival.
Trial design
Surgery + sorafenib vs. sorafenib 100 patients per arm Centralized randomization by CRO Need to call CRO for treatment allocation Primary end-point - OS Secondary end-point Progression free survival (PFS) Randomized 1:1 Stratification Vp1-2 vs. Vp3 AFP ≤400 vs AFP >400 Intention to treat Surgery aborted or R1-2 resection will remain in surgical arm No cross over CT scan chest/abdomen 4 weeks after surgery as post-operative baseline Will not alter treatment allocation Will allow for PFS measurement in surgical arm CT scan chest/abdomen pelvis Q 12 weeks after initiation sorafenib Patients progressing on sorafenib allowed 2nd line treatment Regorafenib or lenvatinib - if approved in China Dose reduction sorafenib as per protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery plus sorafenib | Experimental | surgical resection followed by adjuvant sorafenib |
|
| sorafenib only | Active Comparator | sorafenib only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatic resection | Procedure | removal of portion of liver containing cancer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | time from randomization to death | 2-3 year |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | time from initiation of intervention until progression as defined by RESIST | 3-12 months |
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Inclusion Criteria:
Diagnosis of HCC A) 1st diagnosis of HCC - no prior treatments of HCC B) Diagnosis made by contrast enhanced CT or MRI with arterial and portal phases
a. Platelet count ≥ 100,000 b. No evidence of varices or splenomegaly on imaging c. No ascites ECOG performance status 0-1 Tumor characteristics A) Size of largest tumor ≤ 10cm B) <50% of liver volume involved by tumor C) Multiple tumors allowed D) All tumors all confined to same lobe as PV involvement E) Hepatic Vein or Inferior Vena Cava involvement excluded Non-contrast CT of chest A) No lung metastases B) Involvement of gallbladder and diaphragm allowed C) Involvement of omentum allowed D) Involvement of abdominal wall allowed E) Involvement of colon, stomach, duodenum excluded
Exclusion Criteria:
Unable to provide informed consent Age <18 years Unable to take anti-viral medication for hepatitis B Unable to take sorafenib Medically unfit for surgery Prior malignancy other than those specifically allowed by study Prior treatment of HCC Tumor characteristics A) HCC >10cm B) Bilobar tumor C) Mixed cholangiocarcinoma HCC D) Extra-hepatic tumor E) Tumor involving stomach, duodenum or colon F) Tumor involving hepatic veins or vena cava G) Tumor involving portal vein bifurcation
Liver disease A) Liver function decompensated beyond Child's B7 B) Significant portal hypertension - splenomegaly, varices, ascites or platelet count <100,000 C) Co-infection with HBV and HCV D) Co-infection with HIV ECOG performance status >1
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-Hua Guan, MD | Contact | +8613501673307 | weiyu.wang@tigermed.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital | Recruiting | Shanghai | China |
Data will not be shared
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
| Fujian Cancer Hospital | OTHER_GOV |
| Wenzhou People's Hospital | OTHER |
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| Sorafenib |
| Drug |
sorafenib either as adjuvant therapy after resection or as only treatment |
|
| D008107 |
| Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |