Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma (YYFZTIHBVHCC)

Capital Medical University

Status and phase: Completed; Early Phase 1

Conditions: Hepatocellular Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02927626

BeijingDH

Details and patient eligibility

About

Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
2. Ages Eligible for Study: ≤75 years old;
3. TCM syndrome is deficiency of both Qi and Yin;
4. Confirmed of CHB;
5. Surgery cannot be allowed;
6. Informed consent from the patient.

Exclusion criteria

1. Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
2. Serious problem of heart, lung, or kidney with severe dysfunction;
3. Pregnant or child breast feeding women;
4. Mental or cognitive disorders;
5. Participating in other drug trials;
6. 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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132 participants in 2 patient groups, including a placebo group

Yang Yin Fu Zheng therapy

Experimental group

Treatment:

Drug: Routine medical care

Drug: Yang Yin Fu Zheng therapy

Routine medical care

Placebo Comparator group

Treatment:

Drug: Routine medical care