1.3 Research Implementation Plan

1.3 Research Implementation Plan

1.3.1 Source of Cases

A randomized controlled trial design was adopted, randomly assigning the 70 eligible inpatients from the Department of Integrated Traditional Chinese and Western Medicine of Gansu Provincial Tumor Hospital into treatment and control groups in a 1:1 ratio, with 35 cases in each group.

1.3.2 Randomization Method

Case grouping was conducted using simple randomization. Based on the order of admission, a random number table was used: starting from the leftmost column, 70 consecutive numbers were selected horizontally; odd numbers were assigned to the treatment group, and even numbers to the control group.

1.3.3 Treatment Methods

Basic Treatment: Symptomatic support treatment including liver protection, diuresis, and antiemetics.

Pei’s Soft Liver and Anti-Bloating Pills: Taken orally after breakfast and dinner, one packet twice daily with water.

Composition of Pei’s Soft Liver and Anti-Bloating Pills: Bupleurum, Astragalus, Salvia miltiorrhiza, Sparganium stoloniferum, Curcuma wenyujin, Laminaria japonica, Kelp, Manis pentadactyla, Zanthoxylum bungeanum, Melia azedarach, processed Myrrh, Hedyotis diffusa, Scutellaria barbata, etc.

Specification: 6 g/packet

Manufacturer: Gansu Provincial Academy of Medical Sciences

Batch Number: 090210

Control Group: Basic treatment

Treatment Group: Basic treatment + Pei’s Soft Liver and Anti-Bloating Pills

1.3.4 Treatment Course

One month constitutes one treatment course. Before and after treatment, each group completes detailed clinical observation forms, and at the end of the course, efficacy is evaluated according to established criteria.

1.3.5 Observation Indicators and Methods

1.3.5.1 Objective Efficacy Assessment of Tumor Mass: Use ultrasound, CT, and other examination methods to conduct one examination before and one after treatment for comparison.

1.3.5.2 Quality of Life Improvement: Assessed using the Karnofsky Performance Status Scale.

1.3.5.3 Evaluation of Improvements in Patient Blood Analysis, Liver and Kidney Function, and Tumor Markers (AFP)

• 1.3.5.3.1 Blood Analysis: White blood cells (WBC), red blood cells (RBC), hemoglobin (HGB)
• 1.3.5.3.2 Liver Function Tests: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (γ-GT)
• 1.3.5.3.3 Kidney Function Tests: Blood urea nitrogen (BUN), serum creatinine (Cr)
• 1.3.5.3.4 Tumor Markers: Alpha-fetoprotein (AFP)

1.3.6 Criteria for Efficacy Assessment

1.3.6.1 Criteria for Objective Efficacy Assessment of Solid Tumors

Based on the WHO Solid Tumor Response Evaluation Criteria, the objective efficacy of the tumor mass is assessed as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). CR + PR + SD are considered effective.

• Effective rate = [(CR + PR) / (CR + PR + SD + PD)] × 100%
• Disease stabilization rate = [(CR + PR + SD) / (CR + PR + SD + PD)] × 100%

1.3.6.2 According to the Karnofsky Performance Status Scale, any patient whose score increases by 10 points or more after treatment compared with before is considered improved; if the score decreases by 10 points or more, it is considered deteriorated; if the change in quality of life score between pre- and post-treatment falls between these two extremes, it is considered stable.

1.3.7 Criteria for Termination and Withdrawal from Clinical Trials

1.3.7.1 Carefully record the reasons for trial termination and their relationship to this clinical trial.

1.3.7.1.1 Patients who cannot adhere to treatment. 1.3.7.1.2 Patients who experience severe adverse reactions. 1.3.7.1.3 Patients who develop serious complications during the trial. 1.3.7.1.4 Patients whose symptoms worsen and require emergency intervention.

1.3.7.2 For patients who voluntarily withdraw from the clinical trial midway, clearly record the reason for withdrawal and detail the evaluation indicators at the time of termination.

1.3.8 Clinical Research Records

1.3.8.1 All cases are observed according to the above protocol, and clinical investigation forms are carefully completed.

1.3.8.2 Carefully record patient medication use, providing detailed records and explanations for on-time medication, missed doses, and no medication.

1.3.8.3 Clinical investigation forms serve as original materials and must not be altered; only supplementary notes may be added, along with signatures and dates.

1.3.8.4 All relevant experimental data during the experiment must be recorded.

1.3.8.5 Experimental data within the normal range should also be recorded, while significantly abnormal data must be verified.

1.3.9 Statistical Analysis

Statistical analysis: Data processing uses SPSS 17.0 statistical software. Measurement data are expressed as mean ± standard deviation (x̄±s); intergroup comparisons use the independent samples t-test; within-group pre- and post-treatment comparisons use the paired t-test; count data comparisons use the χ² test; ordinal data two-sample comparisons use the rank-sum test; P ≤ 0.05 indicates statistically significant differences.

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