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Completed

NCT Number: NCT07321613

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

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).

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Key information

Conditions

Hepatocellular Cancer (HCC) Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thalidomide (50mg)

Drug

Thalidomide tablets (Changzhou Pharmaceutical Factory, 50 mg qn)

carmofur

Drug

carmofur tablets (Qilu Pharmaceutical, 100 mg, tid)

compound mylabris capsule

Drug

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

TACE

Procedure

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

Primary outcomes

  1. Overall Survival (OS)

    Time frame: up to five years

    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).

Secondary outcomes

  1. Objective Response Rate (ORR) at 6 Months

    Time frame: up to six 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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