Effect of TCC Cocktail Combined With TACE Versus TACE Alone on Survival in uHCC Patients

Effect of Thalidomide, Carmofur and Compound Mylabris Capsules (TCC) Cocktail Combined With Transarterial Chemoembolization Versus Transarterial Chemoembolization Alone on Survival in Patients With Unresectable Hepatocellular Carcinoma

This is a multicenter, retrospective cohort study that aims to evaluate the efficacy and safety of a triple-drug cocktail (TCC), consisting of Thalidomide, Carmofur, and Compound Mylabris Capsules (CMC), in combination with conventional Transarterial Chemoembolization (TACE) for the treatment of patients with unresectable Hepatocellular Carcinoma (HCC).

Study Overview

• Status: Completed
• Conditions: Hepatocellular Cancer (HCC)
• Intervention / Treatment: Drug: Thalidomide (50mg); Drug: carmofur; Drug: compound mylabris capsule; Procedure: TACE

• Study Type: Observational
• Enrollment (Actual): 545

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This multicenter, retrospective cohort study included adult patients (≥18 years old) diagnosed with unresectable hepatocellular carcinoma (HCC). The diagnosis was made according to the Chinese guidelines for the diagnosis and treatment of primary liver cancer (relevant edition). All patients received initial treatment with conventional transarterial chemoembolization (TACE).

Description

Inclusion Criteria:

• patients who met the HCC diagnostic criteria according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China.
• patients underwent conventional TACE.
• availability of complete medical records for data extraction and follow-up.

Exclusion Criteria:

• a history of previous or synchronous treatment for tumors such as radio frequency ablation (RFA) or systemic chemotherapy.
• poor liver functions (Child-Pugh class C).
• accompanying other life-threatening diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TACE+cocktail; Patients in the TACE+cocktail group received TACE and took the combined oral medications daily, which consisted of thalidomide tablets, carmofur tablets , and compound mylabris capsule.	Drug: Thalidomide (50mg); Thalidomide tablets (Changzhou Pharmaceutical Factory, 50 mg qn); Drug: carmofur; carmofur tablets (Qilu Pharmaceutical, 100 mg, tid); Drug: compound mylabris capsule; CMC (Guizhou Yibai Pharmaceutical Co., Ltd, 750 mg, bid); Procedure: TACE; received initial treatment with traditional TACE by well-trained and experienced physicians
TACE only; Patients in the TACE only group received only TACE treatment.	Procedure: TACE; received initial treatment with traditional TACE by well-trained and experienced physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Defined as the time interval from the date of the patient's first TACE treatment to the date of death from any cause or the date of the last follow-up (whichever occurred first).	up to five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) at 6 Months	The proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to mRECIST criteria at the 6-month follow-up after treatment initiation.	up to six months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Thalidomide; carmofur
• Other Study ID Numbers: 20251111101713560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No