Hepatocellular Cancer (HCC)NCT07321613
Effect of TCC Cocktail Combined With TACE Versus TACE Alone on Survival in uHCC Patients
An observational study of Hepatocellular Cancer (HCC), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer (HCC)
- What is being tested?
- Thalidomide (50mg), carmofur and compound mylabris capsule
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 545 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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)
- Being tested
- Thalidomide (50mg), carmofur, compound mylabris capsule, TACE
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide (50mg)Drug
Thalidomide tablets (Changzhou Pharmaceutical Factory, 50 mg qn)
carmofurDrug
carmofur tablets (Qilu Pharmaceutical, 100 mg, tid)
compound mylabris capsuleDrug
CMC (Guizhou Yibai Pharmaceutical Co., Ltd, 750 mg, bid)
TACEProcedure or surgery
received initial treatment with traditional TACE by well-trained and experienced physicians
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Thalidomide (50mg); Drug: carmofur; Drug: compound mylabris capsule; Procedure: TACE | |
| TACE only | Patients in the TACE only group received only TACE treatment. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to five years
Secondary outcomes (1)
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.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 May 2023
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Cancer (HCC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321613
- Sponsor's protocol ID
- 20251111101713560
- Status last verified
- May 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07321613
- Acronym / sponsor ID
- 20251111101713560
- Conditions
- Hepatocellular Cancer (HCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+cocktail | – | Drug: Thalidomide (50mg), Drug: carmofur, Drug: compound mylabris capsule, Procedure: TACEPatients 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. |
| TACE only | – | Procedure: TACEPatients in the TACE only group received only TACE treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide (50mg)Thalidomide tablets (Changzhou Pharmaceutical Factory, 50 mg qn) | Drug | TACE+cocktail |
| carmofurcarmofur tablets (Qilu Pharmaceutical, 100 mg, tid) | Drug | TACE+cocktail |
| compound mylabris capsuleCMC (Guizhou Yibai Pharmaceutical Co., Ltd, 750 mg, bid) | Drug | TACE+cocktail |
| TACEreceived initial treatment with traditional TACE by well-trained and experienced physicians | Procedure or surgery | TACE only, TACE+cocktail |
Primary outcome
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).
1 secondary outcome
Objective Response Rate (ORR) at 6 Months
Time frame: up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Cancer (HCC), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.