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

NCT07321613 | Completed

• 1 other identifier: 20251111101713560
• Study Type: observational
• Target: 545
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hepatocellular Cancer (HCC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective Response Rate (ORR) at 6 Months

  up to six months

Study Arms (2)

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); Drug: carmofur; Drug: compound mylabris capsule; Procedure: TACE

TACE only

Patients in the TACE only group received only TACE treatment.

Procedure: TACE

Interventions

Thalidomide (50mg) DRUG

Thalidomide tablets (Changzhou Pharmaceutical Factory, 50 mg qn)

TACE+cocktail

carmofur DRUG

carmofur tablets (Qilu Pharmaceutical, 100 mg, tid)

TACE+cocktail

compound mylabris capsule DRUG

CMC (Guizhou Yibai Pharmaceutical Co., Ltd, 750 mg, bid)

TACE+cocktail

TACE PROCEDURE

received initial treatment with traditional TACE by well-trained and experienced physicians

TACE only; TACE+cocktail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Thalidomide; carmofur

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)