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Hepatocellular CarcinomaPhase 3TORCHNCT02435953

TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma

A Phase 3 study testing TACE and RFA in people with Hepatocellular Carcinoma and Chemoembolization, Therapeutic, run by Ming Zhao at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter arterial chemoembolization (TACE) alone. The combination of TACE with RFA has also reported to be an effective treatment for HCC. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TACE and RFA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
1 siteChina
Study dates
May 2015to Oct 2025
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Multiple HCC (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple HCC (4-10 lesions), each ≤ 7 cm in diameter
  • No vascular invasion or etrahepatic metastases
  • Eastern Cooperative Oncology Group Performance Status 0
  • Child-Pugh Stage A or B7
  • Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to procedure:
  • I.Adequate hematologic function:
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  • WBC ≥ 4.0 x 109/L (stable, off any growth factor within 4 weeks of study drug administration)
  • Neutrophils ≥ 1.5 x 109/L (stable, off any growth factor within 4 weeks of study drug administration)
  • Platelets ≥ 60 x 109/L (transfusion to achieve this level is not permitted)
  • Hemoglobin ≥ 100 g/L (may be transfused to meet this requirement)
  • II.Adequate hepatic function:
  • Serum Aspartate Aminotransferase (AST) ≤ 5×ULN
  • Serum Alanine Aminotransferase (ALT) ≤ 5×ULN
  • Serum total bilirubin ≤ 51.3 μmol/L
  • Serum albumin ≥ 2.8 g/dL
  • III.Adequate coagulation function:
  • a)prothrombin activity ≥ 40%
  • IV.Adequate renal function:
  • a)Serum creatinine < 110 μmol/L

Who cannot join

  • Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1
  • Any contraindications for TACE/RFA procedure:
  • I.Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 40%) II.Renal failure / insufficiency requiring hemodialysis or peritoneal dialysis. III.Known severe atheromatosis IV.Known uncontrolled blood hypertension (> 160/100 mmHg) V.Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy VI.Clinically significant third space fluid accumulation (i.e., ascites requiring tapping despite use of diuretic or pleural effusion that either required tapping or is associated with shortness of breath)
  • Evidence of hepatic discompensation (i.e., refractory ascites, esophageal or gastric variceal bleeding, or hepatic encephalophathy)
  • Patients with any other malignancies within the last 3 years before study start
  • History of HCC tumor rupture
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  • Clinically significant (CTC grade 3 or 4) venous or arterial thrombotic disease within past 6 months
  • History of abdominal fistula, GI perforation, or intra-abdominal abscess within past 6 months prior to study treatment
  • Pregnant women or lactating women
  • Be allergic to pirarubicin, lobaplatin and iodized oil

Trial locations and contacts

1 site in 1 country.

China1 site

  • Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,

    Guangzhou, Guangdong, 500060

Other trials in China

About this study

Official title: Transarterial Chemoembolization Plus Radiofrequency Ablation Versus Transarterial Chemoembolization Alone for Intermediate-stage Hepatocellular Carcinoma

The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter arterial chemoembolization (TACE) alone. The combination of TACE with RFA has also reported to be an effective treatment for HCC. Some prospective studies have shown that TACE combined with RFA have better efficacy than any of them alone for early stage HCC (single tumor ≤5 cm). However, to the investigators' knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than TACE alone for the treatment of intermediate-stage HCC. The investigators hypothesized that the combination of TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions, largest tumor size ≤7 cm; ECOG-PS 0; Child-pugh A or B7; no tumor thrombus or extrahepatic metastases.

Being tested
TACE, RFA
Keywords
Hepatocellular Carcinoma,TACE,Chemoembolization, RFA,Intermediate-stage
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TACEProcedure or surgery

    A catheter (or a microcatheter for cases where small vessels and branches cannot be accessed with a standard angiographic catheter) will be advanced selectively or superselectively into the right or left hepatic artery or the feeding arteries directly supplying the tumor. Depending on tumor size, location, blood supply, and liver function, the interventional radiologist administers a cytotoxic agent and lipiodol emulsion (30 mg lobaplatin, 30 mg pirarubicin, and < 15 mL lipiodol) through the catheter. Following drug infusion, embolization of the tumor vessels will be routinely performed using gelatin sponge particles.

  • RFAProcedure or surgery

    Commercial electrode systems are used and the ablation therapy is to be performed according to manufacturer's standard recommendations. All lesions are targeted with CT images during the RFA procedure.

Study groups in NCT02435953
Study groupRoleWhat they receive
TACE-RFAExperimentalRFA follows TACE when achieving ablation eligibility criteria defined in this study, with no more than four sessions of TACE.
Receives: Procedure: TACE; Procedure: RFA
TACE aloneActive comparatorOn-demand TACE.
Receives: Procedure: TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (PFS-R)

    Measured: From the date of randomization to the date of occurrence of radiologic disease progression as determined according to the RECIST v1.1, or death (by any cause), whichever occurs first, assessed up to 10 years.

Secondary outcomes (6)

  1. Overall survival (OS)

    Measured: From the date of randomization to the date of death (due to any cause), assessed up to 10 years.

  2. Progression-free survival (PFS) according to HCC modified RECIST (PFS-m)

    Measured: From the date of randomization to the date of occurrence of radiologic disease progression as determined according to the HCC modified RECIST, or death (by any cause), whichever occurs first, assessed up to 10 years.

  3. unAblation-TACEable or unTACEable progression-free survival (uAT-PFS)

    Measured: From the date of randomization to the date of the following untreatable progression or death by any cause, assessed up to 10 years.

  4. Objective response rate (ORR) according to mRECIST (ORR-m)

    Measured: From date of randomization until the date of study completion, an average of 8 months.

  5. Disease control rate (DCR) according to mRECIST (DCR-m)

    Measured: From date of randomization until the date of study completion, an average of 8 months.

  6. Adverse Events

    Measured: From enrollment to until 30 days following discontinuation of study treatment or until the initiation of the first subsequent therapy following discontinuation of study treatment (whichever occurs first).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionOct 2025
  4. Study completionOct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02435953
Sponsor's protocol ID
2014-FXY-089
Acronym
TORCH
Status last verified
Mar 2026
First submitted
3 May 2015
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lyu N, Yi JZ, Wu XT, Zhang YM, Pan T, Mu LW, Chen S, Wang JL, Xu J, Tan GJ, Zhang YN, Gao ZQ, Ou-Yang ZX, Wu WJ, Song YJ, Deng HJ, He M, Jiang YQ, Chen QF, Li JB, Shi M, Chen MS, Zhao M. Transarterial Chemoembolization Plus Thermal Ablation in Unresectable Hepatocellular Carcinoma: The Phase 3 TORCH Randomized Clinical Trial. JAMA Oncol. 2026 Jul 30:e262366. doi: 10.1001/jamaoncol.2026.2366. Online ahead of print.

    PubMed 42530948

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TACE and RFA in people with Hepatocellular Carcinoma and Chemoembolization, Therapeutic, run by Ming Zhao 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 19 inclusion and 10 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 31 Mar 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (PFS-R) (time frame: From the date of randomization to the date of occurrence of radiologic disease progression as determined according to the RECIST v1.1, or death (by any cause), whichever occurs first, assessed up to 10 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02435953, which also lists 1 linked publication.

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 31 Mar 2026.

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