Effect of Babaodan on Tumor Recurrence After Curative Resection of Hepatocellular Carcinoma

NCT03515369 | Unknown Phase 4 DMC

• 1 other identifier: EHBHKY2017-01-016
• Study Type: interventional
• Target: 459
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the effect of traditional Chinese medicine Babaodan on tumor recurrence of hepatocellular carcinoma after curative resection, as well as the safety of this treatment

Conditions

Hepatocellular Carcinoma; Tumor Recurrence

Keywords

hepatocellular carcinoma; tumor recurrence; adjuvant therapy; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival

  the proportion of individuals who didn't have tumor recurrence and still alive 3 years after hepatectomy

  3-year

Secondary Outcomes (3)

• disease free survival

  assessed up to 5 years

• overall survival

  assessed up to 5 years

• EORTC QLQ-C30

  through study completion, an average of 3 year

Other Outcomes (1)

• safety and tolerability

  through study completion, an average of 3 year

Study Arms (2)

Hepatectomy plus Babaodan

EXPERIMENTAL

Surgical removal of all lesions and take Babaodan oral capsule after operation

Drug: Babaodan oral capsule

Hepatectomy plus Placebo

PLACEBO COMPARATOR

Surgical removal of all lesions and take Placebo oral capsule after operation

Drug: Placebo oral capsule

Interventions

Babaodan oral capsule DRUG

On the basis of conventional liver protecting treatment, take Babaodan oral capsule within 4 weeks after curative resection. Take two capsules three times daily, two months as a course of treatment and the maximum of eighteen courses, until the recurrence of tumor or death of patients (non tumor related death), or the termination of research.

Also known as: Conventional liver protecting treatment

Hepatectomy plus Babaodan

Placebo oral capsule DRUG

On the basis of conventional liver protecting treatment, take Placebo oral capsule began within 4 weeks after curative resection. Take two capsules three times daily, two months as a course of treatment and the maximum of eighteen courses, until the recurrence of tumor or death of patients (non tumor related death), or the termination of research.

Also known as: Conventional liver protecting treatment

Hepatectomy plus Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years and ≤75 years
• male or female patients
• tumor of BCLC A or B stage (≤3 nodules), and was assessed to be curative resected
• hepatocellular carcinoma confirmed by postoperative pathology, received R0 resection
• without tumor thrombus
• without extrahepatic metastasis
• KPS score ≥80
• Child-Pugh A liver function
• the expected postoperative survival time ≥12 weeks
• the latest laboratory tests met the following requirements before entering the group: 1) hemoglobin ≥8.5g/dl; 2) neutrophils count ≥1,000/mm3; 3) platelet count ≥50,000/ul; 4) total bilirubin ≤2 upper limit of normal; 5) ALT and AST ≤3 upper limit of normal; 6) serum urea nitrogen and creatinine ≤1.5 upper limit of normal
• agree to sign the informed consent

You may not qualify if:

• \>3 tumor nodules
• history of HCC
• history of other tumors, except: 1) in situ carcinoma of cervix; 2) treated basal cell carcinoma; 3) superficial bladder cancer (Ta、Tis and T1); 4) any cancer that received radical treatment more than 3 years
• with serious diseases of heart, brain, lung, kidney and blood system
• received preoperative anti-cancer treatment
• received radiotherapy or chemotherapy during the operation
• pregnant or lactating women
• receiving other clinical trials
• history of allogeneic organ transplantation
• patients known or suspected to be allergic to Babaodan, have allergy history of biological agents, have allergic constitution or being allergic
• patients with hemorrhagic tendency or history of gastrointestinal bleeding within 30 days; severe esophageal varices or have history of esophageal variceal hemorrhage
• cannot take medicine orally
• have HIV infection or AIDS related diseases
• have a history of mental illness or behavioral abnormality, which is assessed not suitable for clinical trials.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• Sun Yat-sen University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Second Military Medical University: collaborator
• Xiamen Traditional Chinese Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng Shen, MD, PhD

  Eastern Hepatobiliary Surgery Hospital, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Feng Shen, MD, PhD

CONTACT

0086-21-81875005; shenfengehbh@sina.com

Kui Wang, MD

CONTACT

13636330827; wangkuiykl@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Professor and Chief Surgeon; Member-at-large of International Hepato-Pancreato-Biliary Association (IHPBA); Secretary of Asia-Pacific Hepato-Pancreato-Biliary Association (A-PHPBA)

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 3, 2018
• Study Start: May 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 3, 2018

Record last verified: 2018-05