A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion

NCT03971201 | Unknown Phase 2 FDA Drug

• 1 other identifier: 20190507
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Cancer

Keywords

portal vein invasion

Outcome Measures

Primary Outcomes (1)

• overall survival

  time from randomization to death

  2-3 year

Secondary Outcomes (1)

• progression free survival

  3-12 months

Study Arms (2)

Surgery plus sorafenib

EXPERIMENTAL

surgical resection followed by adjuvant sorafenib

Procedure: hepatic resection; Drug: Sorafenib

sorafenib only

ACTIVE COMPARATOR

sorafenib only

Drug: Sorafenib

Interventions

hepatic resection PROCEDURE

removal of portion of liver containing cancer

Surgery plus sorafenib

Sorafenib DRUG

sorafenib either as adjuvant therapy after resection or as only treatment

Surgery plus sorafenib; sorafenib only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Arterial enhancement
• Venous washout
• Expanding/enhancing tumor thrombus seen in portal vein Extent of HCC spread A) Vp1-3 (Japanese system) - VP1-2 (Cheng criteria - Shanghai) B) No involvement of main portal vein Vp4 (Japanese system) - Vp3 Shanghai C) No evidence of extra-hepatic spread in abdomen D) No evidence of hepatic vein or vena cava invasion Need for Biopsy A) Patients not meeting above criteria B) Absence of underlying liver disease Demographics A) Age ≥ 18 Women of reproductive age A) Negative pregnancy test B) Must be on birth control for duration of study Able to provide informed consent No prior malignancy A) Excluding basal/squamous cell skin cancers B) Excluding superficial bladder cancer C) Excluding cervical cancer Underlying liver disease A) HBV, HCV, alcohol, or none B) All HBV patients must be placed on anti-viral therapy prior to any treatment and continue through entire study C) Co-infection HBV with HCV excluded D) HIV infection excluded Liver function/Performance status A) Child's A or B7 liver function B) Absence of clinical portal hypertension
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• White Plains Hospital: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Sun Yat-sen University: collaborator
• West China Hospital: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• Anhui Provincial Hospital: collaborator
• Fujian Cancer Hospital: collaborator
• Wenzhou People's Hospital: collaborator

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Wei-Hua Guan, MD

CONTACT

+8613501673307; weiyu.wang@tigermed.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 3, 2019
• Study Start: September 6, 2019
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)