Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter (YYFZJDTRHCLT3D)

Capital Medical University

Status and phase: Completed; Early Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Other: Routine medical care; Drug: Yang Yin Fu Zheng Jie Du therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04264962

BeijingDHYZY

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Yang Yin Fu Zheng Jie Du therapy

Experimental group

Treatment:

Drug: Yang Yin Fu Zheng Jie Du therapy

Other: Routine medical care

Routine medical care

Placebo Comparator group

Treatment:

Other: Routine medical care