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Hepatocellular CarcinomaPhase 2NCT05003700

Hepatic Arterial Infusion Combined With Lenvatinib and Camrelizumab for Unresectable Hepatocellular Carcinoma

A Phase 2 study testing Hepatic arterial infusion chemotherapy, Lenvatinib and Camrelizumab in people with Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University 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 purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin and raltitrexed plus lenvatinib and camrelizumab in patients with unresectable hepatocellular carcinoma (HCC). 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?
Hepatic arterial infusion chemotherapy, Lenvatinib and Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
12 Aug 2021to 4 Jul 2024
Phase
Phase 2
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

  • The patient voluntarily joins the study and signs an informed consent;
  • Age ≥ 18 years old, ≤ 75 years old, both men and women;
  • Clinical or pathologically confirmed BCLC B(tumor numbers≥4) or C-stage hepatocellular carcinoma, no further first-line treatment;
  • At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary tumor burden;
  • Child-Pugh score small or equal to 7 points (Child-Pugh A-B);
  • The maximum liver tumor diameter ≥7cm;
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  • ECOG score: 0 to 1 (according to the ECOG score classification);
  • The expected survival is longer than 12 weeks;
  • The laboratory parameters meets the following requirements (no blood components and cell growth factors are allowed within 14 days before the first dose):
  • Absolute neutrophil count ≥ 1.5 × 109 / L; Platelets ≥ 50 × 109 / L; Hemoglobin ≥ 80 g / L; serum albumin ≥ 28 g / L; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled); bilirubin ≤ 1.5 × ULN (within 7 days prior to the first dose); ALT ≤ 3 x ULN and AST ≤ 3 x ULN (within 7 days prior to the first dose); AKP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN;
  • For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Camrelizumab injection.

Who cannot join

  • The patient has any active auto-immune disease or a history of auto-immune disease;
  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
  • The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment;
  • Known central nervous system tumors including metastatic brain disease;
  • Known history of HIV;
  • History of organ allograft;
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  • Known or suspected allergy to the investigational agents or any agent given in association with this trial;
  • Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥90 mmHg);
  • Evidence of bleeding diathesis;
  • Patients with clinically significant gastrointestinal bleeding within 3 months prior to study entry.
  • Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Suffering heart diseases with clinical symptoms or those not well controlled, such as: (1) heart failure in NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction occurred within 1 year; (4) clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Tc > 450ms (male); QTc > 470ms (female);
  • Urine routine indicates that urine protein ≥ ++ and 24-hour urine protein amount > 1.0g was confirmed;
  • The patient has active infection, unexplained fever (≥38.5 °C) within 3 days before administration, or baseline white blood cell count>15×109/L;
  • Patients with congenital or acquired immunodeficiency (such as HIV-infected patients);
  • HBV-DNA>2000 IU/ml (or 104 copies/ml); or HCV-RNA>103 copies/ml; or HBsAg+ and anti-HCV antibody positive patients;
  • The patient has had other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
  • Patients have previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or have received apatinib before;
  • Inoculation of a live vaccine within less than 4 weeks prior to study or possibly during the study period;
  • Pregnant or lactating women, or women of childbearing age who are unwilling to take contraceptive measures;
  • According to the investigators, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory tests, abnormalities, accompanied by factors such as family or society, which may affect the safety of enrolled patients.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Camrelizumab for Unresectable Hepatocellular Carcinoma：a Prospective, Single-arm，Phase II Trial.

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin and raltitrexed plus lenvatinib and camrelizumab in patients with unresectable hepatocellular carcinoma (HCC).

Read the detailed description

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin and raltitrexed was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated HAIC of oxaliplatin and raltitrexed plus lenvatinib and camrelizumab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Being tested
Hepatic arterial infusion chemotherapy, Lenvatinib, Camrelizumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Hepatic arterial infusion chemotherapyProcedure or surgery

    administration of oxaliplatin and raltitrexed via the tumor feeding arteries every 3 weeks.

  • LenvatinibDrug

    Also called Lenvima

    8 mg once daily (QD) oral dosing.

  • CamrelizumabDrug

    200mg intravenously every 3 weeks.

Study groups in NCT05003700
Study groupRoleWhat they receive
HAIC(RALOX) plus Lenvatinib and CamrelizumabExperimentalHepatic arterial infusion of oxaliplatin and raltitrexed every 3 weeks. Lenvatinib 8 mg once daily (QD) oral dosing. Camrelizumab 200mg intravenously every 3 weeks.
Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: Camrelizumab

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1

    Measured: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

Secondary outcomes (7)

  1. The disease control rate (DCR)

    DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1

    Measured: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

  2. Duration of response (DOR)

    DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1

    Measured: From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)

  3. Progression free survival rate at 12 months

    The progression free survival time defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1

    Measured: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)

  4. Overall survival rate at 12 months

    OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

    Measured: From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)

  5. The median progression free survival time (mPFS)

    The progression free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1

    Measured: From date of first dose of study drug to the date of first documentation of disease progression (up to approximately 3 years)

  6. The median overall survival time (mOS)

    OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

    Measured: From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety will be evaluated according to the NCI CTCAE Version 5.0. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

    Measured: From the start date of the Treatment Phase until date of death from any cause (up to approximately 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 posted12 Aug 2021
  2. Study start12 Aug 2021
  3. Primary completion26 May 2023
  4. Study completion4 Jul 2024

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003700
Sponsor's protocol ID
NFEC-2020-130
Status last verified
Nov 2024
First submitted
1 Aug 2021
Last updated
5 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hepatic arterial infusion chemotherapy, Lenvatinib and Camrelizumab in people with Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University 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 11 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: finished, as of the sponsor's last update on 5 Nov 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective response rate (ORR) (time frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 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 NCT05003700.

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 5 Nov 2024.

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