1 Clinical Data

1 Clinical Data

1.1 Source of Cases

Seventy newly diagnosed or recurrent PLC patients who met the case selection criteria were collected from December 2011 to December 2012 at the Department of Integrated Traditional Chinese and Western Medicine of Gansu Provincial Tumor Hospital.

1.2 Case Selection

1.2.1 Inclusion Criteria

1.2.1.1 Compliance with the “Clinical Diagnosis and Staging Standards for Primary Liver Cancer” adopted by the Liver Cancer Professional Committee of the Chinese Anti-Cancer Association in 2001 [16]:

1.2.1.1.1 Alpha-fetoprotein (AFP) ≥ 400 μg/L, excluding pregnancy, germ cell tumors, active liver disease, and metastatic liver cancer, and with palpable enlarged, hard, nodular liver masses or imaging findings showing space-occupying lesions characteristic of liver cancer.

1.2.1.1.2 AFP < 400 μg/L, excluding pregnancy, germ cell tumors, active liver disease, and metastatic liver cancer, and with two imaging examinations showing space-occupying lesions characteristic of liver cancer, or two liver cancer biomarkers positive, such as des-gamma-carboxy prothrombin (abnormal prothrombin DCP), gamma-glutamyl transferase isoenzyme II (γ-GGTII), alpha-L-fucosidase (AFU), and carbohydrate antigen 19-9 (CA19-9), along with one imaging examination showing space-occupying lesions characteristic of liver cancer.

1.2.1.1.3 Presence of clinical manifestations of liver cancer and definite extrahepatic metastatic lesions (including visible bloody ascites or detection of cancer cells therein), excluding metastatic liver cancer.

1.2.1.2 Compliance with the “Clinical Diagnosis and Staging Standards for Primary Liver Cancer” adopted at the Eighth National Liver Cancer Academic Conference in September 2001, selecting PLC patients in stages II and III.

1.2.1.3 Karnofsky performance status score ≥ 60 points.

1.2.1.4 Age between 18 and 75 years.

1.2.1.5 Having completed anti-tumor treatments such as surgery, radiotherapy, chemotherapy, interventional therapy, or radiofrequency ablation more than one month ago, yet still having solid tumors, and being unsuitable or refusing further chemotherapy, radiotherapy, surgery, or intervention.

1.2.1.6 Estimated survival period ≥ 2 months.

1.2.1.7 Voluntary consent to participate in this study, signing an informed consent form, and good compliance.

1.2.2 Exclusion Criteria

1.2.2.1 Secondary liver cancer.

1.2.2.2 Patients with severe concurrent cardiovascular, cerebrovascular, renal, hematopoietic, or other primary diseases, as well as psychiatric patients.

1.2.2.3 Pregnant and lactating women.

1.2.2.4 Patients concurrently taking other traditional Chinese medicinal anti-cancer preparations or immunomodulators.

1.2.2.5 Poor compliance, failure to take medication as prescribed, or cases with incomplete data that make it impossible to assess efficacy.

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