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Hepatocellular CarcinomaNCT05621499

HAIC or Lenvatinib Combined With Sintilimab for High Recurrence Risk Resectable Solitary Hepatocellular Carcinoma

A study testing HAIC, Sintilimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the safety and efficacy of HAIC or Lenvatinib combined with Sintilimab as a neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
HAIC, Sintilimab and Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
20 Dec 2022to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Volunteer to join the study and signed the informed consent form
  • Aged 18-75, male or female
  • ECOG PS score 0-1
  • Child Pugh liver function Grade A
  • Histopathology confirmed primary hepatocellular carcinoma (HCC) and the lesion met the indications for surgical resection in the Diagnostic and Therapeutic Norms for Primary Liver Cancer (2022)
  • According to the investigator's assessment, there are the following high recurrence risk factors, Stage Ⅰ b: solitary tumor, with the largest diameter > 5cm
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  • At least one measurable lesion according to RECIST 1.1 (measurable lesion CT/MRI scan length diameter ≥ 10mm or lymph node lesion CT/MRI scan short diameter ≥ 15mm, and measurable lesion has not received radiotherapy, cryotherapy and other local treatments)
  • Expected life ≥ 6 months
  • Functions of important organs shall meet the following requirements (excluding the use of any blood component and cell growth factor within 14 days) Neutrophils ≥ 1500/mm3Platelet count ≥ 60,000/mm3Hemoglobin ≥ 5.6 mmol/L (9 g/dL); Serum creatinine (SCR) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); The level of AST or ALT ≤ 2.5 times the upper limit of normal value (ULN); Urine protein<2+; If urinary protein ≥ 2+, the 24-hour urine protein quantitative display must be ≤ 1g
  • Normal coagulation function, no active bleeding and thrombosis disease
  • International normalized ratio INR ≤ 1.5 × ULN；
  • Partial thromboplastin time APTT ≤ 1.5 × ULN；
  • Prothrombin time PT ≤ 1.5ULN;
  • Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the medication period and within 6 months after the end of medication; If the serum or urine pregnancy test was negative within 7 days before the study included, and the patient must be a non lactating patient, the male should agree to use contraception during the study period and within 6 months after the end of the study period
  • The subjects had good compliance and cooperated with follow-up.

Who cannot join

  • Previously received radiotherapy, chemotherapy, concurrent radiotherapy and chemotherapy or other targeted therapies
  • Known hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; Have other active malignant tumors except HCC within 5 years or at the same time
  • Patients with hypertension who cannot be well controlled after antihypertensive drug treatment (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); Previous hypertension crisis or hypertensive encephalopathy
  • Patients had other malignant tumors in the past or at the same time (except cured skin basal cell carcinoma and cervical carcinoma in situ);
  • Patients who had been treated with Sintilimab or other PD-1/PD-L1 inhibitors in the past could not be included; Known hypersensitivity to macromolecular protein preparations or any excipients of Sintilimab or lenvatinib
  • Patients have any active autoimmune diseases or have a history of autoimmune diseases (Including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or asthma in childhood has completely alleviated, without any intervention after adulthood can be included; Patients with asthma requiring medical intervention of bronchodilators cannot be included)
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  • Patients who are using immunosuppressive agents, or systemic or absorbable local hormone to achieve immunosuppressive purpose (Dose>10mg/day prednisone or other equivalent therapeutic hormones) and continue to use them within 2 weeks before enrollment
  • Ascites or pleural effusion with clinical symptoms and requiring therapeutic puncture or drainage
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as:
  • Heart failure above NYHA level 2
  • Unstable angina pectoris
  • Myocardial infarction occurred within 1 year
  • Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention
  • Patients having gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from tumors that have not been removed, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator at present (within 3 months)
  • Serious bleeding (>30 ml bleeding within 3 months), hemoptysis (>5 ml fresh blood within 4 weeks) or thromboembolism (including stroke and/or transient ischemic attack) occurred in the past or present
  • Patients with active infection or fever of unknown origin>38.5℃during the screening period and before the first administration (according to the judgment of the investigator, subjects with fever due to tumor can be included)
  • Patients with past or current objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of pulmonary function
  • Patients with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria: HBV DNA ≥ 10e4/ml; HCV RNA ≥ 10e3/ml); Chronic hepatitis B virus carriers with HBV DNA<2000 IU/ml (<10e4 copies/ml) receive antiviral treatment at the same time during the trial can be included
  • Live vaccine may be inoculated less than 4 weeks before the study medication or during the study period
  • Known history of abuse of psychotropic substances, alcohol abuse or drug abuse
  • Conditions should be excluded according to the judgment of the investigator, for example, according to the judgment of the investigator, the patient has other factors that may lead to the forced termination of the study, such as other serious diseases requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: The Safety and Efficacy of HAIC or Lenvatinib Combined With Sintilimab as a Neoadjuvant Therapy for High Recurrence Risk Resectable Stage IB Solitary Hepatocellular Carcinoma: a Prospective, Randomized, Two Cohort, Exploratory Study

To evaluate the safety and efficacy of HAIC or Lenvatinib combined with Sintilimab as a neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma

Being tested
HAIC, Sintilimab, Lenvatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • HAICDrug

    Oxaliplatin 85 mg/m2, LV 400 mg/ m2, 5-FU 400 mg/m2 bolus and then 2400 mg/m2 as 46h continuous infusion，Q3W，a total of 2 cycles

  • SintilimabDrug

    Also called IBI308

    200mg，iv，d1，q3w，a total of 2 cycles

  • LenvatinibDrug

    12 or 8mg/kg，po，qd，a total of 2 cycles

Study groups in NCT05621499
Study groupRoleWhat they receive
experimental group1ExperimentalHAIC
Receives: Drug: HAIC
experimental group 2ExperimentalLenvatinib+Sintilimab
Receives: Drug: Sintilimab; Drug: Lenvatinib

What is being measured

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

  1. 1-year DFS rate

    To evaluate the 1-year disease free survival rate of neoadjuvant treatment with HAIC or Lenvatinib combined with Sintilimab for of high recurrence risk resectable stage IB solitary hepatocellular carcinoma

    Measured: up to 1 years

Secondary outcomes (6)

  1. Incidence of microvascular invasion

    Defined as proportion of patients with microvascular invasion

    Measured: Up to 3 years

  2. Pathological complete response rate (pCR)

    Defined as proportion of patients who have a best response of pCR

    Measured: up to 1 years

  3. Objective response rate

    Defined as proportion of patients who have a best response of CR or PR

    Measured: Up to 1 years

  4. 2-year DFS rate

    To evaluate the 2-year disease free survival rate of neoadjuvant treatment with HAIC or Lenvatinib combined with Sintilimab for of high recurrence risk resectable stage IB solitary hepatocellular carcinoma

    Measured: Up to 3 years

  5. 2-year OS rate

    To evaluate the 2-year overall survival rate of neoadjuvant treatment with HAIC or Lenvatinib combined with Sintilimab for of high recurrence risk resectable stage IB solitary hepatocellular carcinoma

    Measured: Up to 3 years

  6. Adverse Events (AEs)

    Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 and complications of surgery

    Measured: Up to 3 years

Timeline

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

  1. First posted18 Nov 2022
  2. Study start20 Dec 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621499
Sponsor's protocol ID
C20221044
Status last verified
Jul 2026
First submitted
10 Nov 2022
Last updated
29 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing HAIC, Sintilimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and 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 15 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 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?

This study is still under way. Results are not available in the source record yet.

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?

1-year DFS rate (time frame: up to 1 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 NCT05621499.

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 29 Jul 2026.

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