## Protocol Section
### Identification Module
**NCT ID:** NCT02447679

**Brief Title:** Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

**Official Title:** Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrent After Hepatectomy in High Risk Patients -A Phase II Study

#### Organization Study ID Info
**ID:** CGMF-IRB-97-1291A
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2017-02-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-02-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01-31

**Type:** ACTUAL

#### Start Date
**Date:** 2010-08

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2015-05-19
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-16
**Study First Submit QC Date:** 2015-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chang Gung Memorial Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide response.

**Detailed Description:** After liver resection to remove the hepatocellular carcinioma completely, the patients with high risk of tumor recurrence will be enrolled into this study. The high risk of tumor recurrence depends on tumor characteristics. The risk factors of tumor characteristics included tumor size \>5 cm in diameter, abscence of encapsulation, vascular invasion and presence of daughter nodules. The patients with high risk of tumor recurrence will have 1 to 3 risk factors. When the patients are enrolled into the study, oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence. The patients will be fillowed uo erevy 3 mnoths.

### Conditions Module

**Conditions:**

- Adult Hepatocellular Carcinoma

- Recurrent Hepatocellular Carcinoma

- Adverse Reaction to Drug

- Vascular Endothelial Growth Factor Overexpression

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 1. Thalidomide 400mg/day for 1 year
2. tegafur-uracil 2 tables for 1 year.

**Intervention Names:**

- Drug: thalidomine

- Drug: tegafur-uracil

**Label:** thalidomine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- thalidomine

**Description:** thalidomine (400mg/day) for 1 year to prevent HCC recurrence

**Name:** thalidomine

**Other Names:**

- thado

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- thalidomine

**Description:** tegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence

**Name:** tegafur-uracil

**Other Names:**

- ufur

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Measure a-fetoprotein and perform liver echo to find out tumor recurrence every 3 month. Then, if a tumor/tumors are found in liver echo, tumor recurrence will be confirmed by CT scan. The imaging on CT shows typical HCC pattern.

The pilot study is to obtain preliminary information on:

* 3-year recurrence-free survival rate
* Recurrence-free survival
* Safety profile of the treatment
* Biomarkers response(VEGF/bFGF)

**Measure:** tumor recurrence

**Time Frame:** every 3 months, up to 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. stage I-III（TNM: T1-T3） hepatocellular carcinoma
2. previously received curative surgery
3. presence at least one and no more than three of the following risk factors ,

i.Tumor size ≧ 5 cm ii.presence of microscopic or macrovascular venous invasion iii.presence of satellite nodules/addition nodules iv.no capsular formation v.multiple tumors d.performance status of ECOG 0, 1 e.age between 20 and 75 years f.no residual or recurrent tumors detected by computed tomography (CT) or echo within 3-6 weeks after surgery g.written informed consent to participate in the trial

Exclusion Criteria:

1. other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
2. previously received chemotherapy
3. less than 2 weeks since previous radiotherapy/surgery
4. white blood cell (WBC) less than 3,000/mm3 and absolute neutrophil count (ANC) less than 1,500/mm3, and platelets less than 100,000/mm3
5. serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
6. alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 5 times the ULN
7. alkaline phosphatase greater than 5 times the ULN
8. presence of serious concomitant illness which might be aggravated by study medication:uncontrolled infection (active serious infections that are not controlled by antibiotics)
9. hypersensitivity to thalidomide or compounds pregnant or breast feeding women, or women of child-bearing potential unless using two reliable and appropriate contraceptive method

**Maximum Age:** 75 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taoyuan

**Country:** Taiwan

**Facility:** Chang Gung Memorial Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Chang Gung Memorial Hospital

**Name:** Wei-Chen Lee

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

- ID: D000064419

- Term: Chemically-Induced Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M30303

- Name: Drug-Related Side Effects and Adverse Reactions

- Relevance: HIGH

- As Found: Adverse Reaction to Drug

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: HIGH

- As Found: Hepatocellular Carcinoma

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11113

- Name: Liver Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000006528

- Term: Carcinoma, Hepatocellular

- ID: D000064420

- Term: Drug-Related Side Effects and Adverse Reactions

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M8760

- Name: Tegafur

- Relevance: HIGH

- As Found: Fasted state

- ID: M16559

- Name: Thalidomide

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005641

- Term: Tegafur

### Misc Info Module

- Version Holder: 2024-05-24
