Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter

Early Phase 1

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Routine medical care; Drug: Yang Yin Fu Zheng Jie Du therapy

• Registration Number: NCT04264962
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-10
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Meet the criteria of hepatocellular carcinoma
• Ages Eligible for Study: ≤75 years old;
• The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm)
• After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)
• Surgery cannot be allowed;
• Informed consent from the patient.

Exclusion Criteria

• Serious problem of heart, lung, or kidney with severe dysfunction;
• Pregnant or child breast feeding women;
• Mental or cognitive disorders;
• Participating in other drug trials;
• Who are allergic to the study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine medical care	Routine medical care	-
Yang Yin Fu Zheng Jie Du therapy	Yang Yin Fu Zheng Jie Du therapy	-
Yang Yin Fu Zheng Jie Du therapy	Routine medical care	-

Primary Outcome Measures

Name	Time	Method
Recurrance rate	1 year

Secondary Outcome Measures

Name	Time	Method
Objective response rate	1 year
quality of life (QOL) questionnaire	1 year

Trial Locations

Locations (1)

Zhiyun Yang; 🇨🇳 Beijing, Beijing, China