TITAN-HCC: Neoadjuvant and Adjuvant QL1706 With TACE in Resectable Hepatocellular Carcinoma Beyond Milan Criteria (TITAN-HCC)

July 30, 2026 updated by: Lunxiu Qin, Fudan University

Neoadjuvant TACE Plus Iparomlimab and Tuvonralimab （QL1706）and Adjuvant QL1706 in Resectable BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria: the TITAN-HCC Phase II Trial

This is a single-arm, single-center, prospective trial designed to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with ipalimab/tuvonralimab (QL1706) in the peri-operative setting for resectable hepatocellular carcinoma exceeding the Milan criteria, and to explore biomarkers predictive of therapeutic response.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years, male or female
  • Patients with histologically or pathologically confirmed hepatocellular carcinoma (HCC), or Patients meeting the clinical diagnostic criteria for hepatocellular carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD)
  • BCLC stage A or B hepatocellular carcinoma deemed amenable to curative-intent surgery after multidisciplinary consultation, yet exceeding Milan criteria
  • Eligible for the TACE procedure predefined by the study center, with no contraindications
  • Child-Pugh score ≤7
  • ECOG PS ≤1
  • Measurable disease per RECIST 1.1 criteria
  • Life expectancy >12 weeks
  • Adequate organ function meeting the following laboratory values: Hematological: Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelet count (PLT) ≥75×10⁹/L Hemoglobin (HGB) ≥90 g/L Hepatic: Total bilirubin (TBIL) ≤3× upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN Serum albumin ≥28 g/L Note: Patients may be enrolled if values stabilize after standard liver support therapy for ≥1 week, as assessed by the investigator. Renal: Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula) Coagulation: International normalized ratio (INR) ≤2×ULN or Activated partial thromboplastin time (APTT) ≤2×ULN
  • Willing and able to provide written informed consent prior to any study-related procedures

Exclusion Criteria:

  • Patients with histopathologically confirmed variant hepatocellular carcinoma (HCC) subtypes, including: Fibrolamellar hepatocellular carcinoma Sarcomatoid hepatocellular carcinoma Mixed hepatocellular-cholangiocarcinoma
  • Prior local therapy targeting the index lesion(s), including but not limited to: Transarterial chemoembolization (TACE) Transarterial embolization (TAE) Transarterial radioembolization (TARE) Hepatic arterial infusion chemotherapy (HAIC) Radiofrequency ablation (RFA) Cryoablation High-intensity focused ultrasound (HIFU) Radiation therapy
  • Prior systemic anti-cancer therapy for hepatocellular carcinoma, including but not limited to: Molecular targeted agents (e.g., tyrosine kinase inhibitors, anti-angiogenic drugs) Conventional chemotherapy Immunotherapy: Immune checkpoint inhibitors (e.g., PD-1/PD-L1/CTLA-4 inhibitors) Immune checkpoint agonists Cellular immunotherapy (e.g., CAR-T, NK cell therapy) Biological therapy: Cancer vaccines Cytokines (e.g., interferons, interleukins) Growth factor inhibitors
  • Presence of portal vein tumor thrombus, hepatic vein or inferior vena cava tumor thrombus, or distant metastasis
  • History of bleeding events within 6 months prior to initial treatment, including but not limited to: Acute hemorrhage from esophageal or gastric varices caused by portal hypertension AND/OR 6. Untreated or inadequately treated
  • Clinically significant cardiovascular or cerebrovascular disease, including any of the following within 3 months prior to initial treatment: Congestive heart failure (NYHA Class ≥II) Myocardial infarction Cerebrovascular accident (stroke/TIA) Unstable arrhythmia Unstable angina OR 8. History of congenital long QT syndrome OR 9. Screening ECG showing QTc interval >500 ms (calculated by Fridericia's formula)
  • Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years prior to initial treatment, with the following exceptions: Non-systemic replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal/pituitary insufficiency)
  • Known HIV-positive status or history of active acquired immunodeficiency syndrome (AIDS)
  • History of allogeneic stem cell transplantation or solid organ transplantation
  • History of other active malignancies within 5 years prior to initial treatment, except for those with negligible risk of metastasis or death (e.g., 5-year overall survival rate >90%), including: Adequately treated carcinoma in situ of the cervix Non-melanoma skin cancer Localized prostate cancer (Gleason score ≤6, treated if required) Superficial bladder cancer (Ta/Tis, non-invasive)
  • Women who are pregnant or breastfeeding
  • Concurrent participation in another clinical trial, unless: It is a non-interventional study (e.g., observational/registry study), OR The patient is in the follow-up phase of an interventional trial, defined as: ≥4 weeks since last dose in the prior trial, OR ≥5 half-lives of the investigational drug (whichever is shorter)
  • Systemic corticosteroid (>10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 2 weeks prior to initial treatment, with the following exceptions: Adrenal replacement therapy (prednisone ≤10 mg/day or equivalent) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption Short-term corticosteroid prophylaxis for hypersensitivity reactions (e.g., premedication for CT scans)
  • Any clinical or laboratory abnormality or compliance issue deemed by the investigator to render the patient unsuitable for enrollment in this clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TACE+QL1706
TACE+QL1706 (PD-1/CTLA-4 antibody, 7.5mg/kg, ivgtt, Q3W)
Combination product: TACE+QL1706
TACE+QL1706(PD-1/CTLA-4 antibody, 7.5mg/kg, ivgtt, Q3W)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major Pathologic Response（MPR）
Time Frame: Periprocedural
In the tumor bed of the surgical resection specimen, necrotic or regressive tumor tissue ≥90 %.
Periprocedural

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 4~6 weeks
4~6 weeks
pCR
Time Frame: Periprocedural
Periprocedural
1 year-RFS
Time Frame: 1 year
1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 1 year after the patient was enrolled in the study
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
1 year after the patient was enrolled in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025-875

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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