- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971201
A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Wei-Hua Guan, MD
- Phone Number: +8613501673307
- Email: weiyu.wang@tigermed.net
Study Locations
-
-
-
Shanghai, China
- Recruiting
- Eastern Hepatobiliary Surgery Hospital
-
Contact:
- Shuqun Cheng, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgery plus sorafenib
surgical resection followed by adjuvant sorafenib
|
removal of portion of liver containing cancer
sorafenib either as adjuvant therapy after resection or as only treatment
|
Active Comparator: sorafenib only
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sorafenib either as adjuvant therapy after resection or as only treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 2-3 year
|
time from randomization to death
|
2-3 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival
Time Frame: 3-12 months
|
time from initiation of intervention until progression as defined by RESIST
|
3-12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- 20190507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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