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Hepatocellular CarcinomaPhase 1NCT06354387

Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1

A Phase 1 study testing Alectinib (Alecensa), Nivolumab (Opdivo) in people with Hepatocellular Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.

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

Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death and the second most deadly malignancy in Taiwan. Despite decades' intensive studies, surgery and local-regional chemo-embolization, radio-frequency ablation or radiation therapy remain the mainstay of HCC treatments. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Alectinib (Alecensa), Nivolumab (Opdivo)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteTaiwan
Study dates
16 Feb 2022to 28 Feb 2026
Phase
Phase 1
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥20 years, at time of signing Informed Consent Form.
  • Histologically confirmed hepatocellular carcinoma, and the HCC cells harbor only wild-typed ALK.
  • Who has failed local treatments and at least one line of standard TKI treatment (sorafenib or lenvatinib) and not eligible for immune check point inhibitor treatment.
  • Life expectancy ≥ 12 weeks
  • At least one measurable (per RECIST 1.1) lesion. Patients who received prior local therapy (e.g., radiofrequency ablation or transarterial chemoembolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1.
  • ECOG Performance Status of 0 or 1 within 7 days prior to registration
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  • Child-Pugh class A (see Appendix) or B7-8 within 14 days prior to registration
  • Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior to registration, unless otherwise specified:
  • ANC ≥ 1.5 *109/L(1500/μL) without granulocyte colony-stimulating factor support; platelet count ≥ 75*109/L(75000/μL) without transfusion; and hemoglobin≥ 90 g/L (9 g/dL)(patients may be transfused to meet this criterion).
  • Liver transaminases (AST and ALT) ≤ 5 *upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 * ULN or creatinine clearance≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
  • Urine dipstick for proteinuria ≤ 2+ (within 7 days prior to initiation of study treatment). Patients who have ≥ 2+ proteinuria on dipstick urinalysis at baseline will be eligible if he/she have daily protein excretion of ≤ 1g documented by a 24-hour urine collection.
  • Women of childbearing potential must agree to use contraceptive methods with a failure rate of < 1% per year (e.g., hormonal contraceptives that inhibit ovulation, copper intrauterine devices) during the treatment period and for at least 6 months after the last dose of Alectinib (Alecensa) in Combination with Nivolumab (Opdivo).
  • Men must agree to use contraceptive measures (condom plus an additional contraceptive method that together result in a failure rate of < 1% per year) during the treatment period and for 6 months after the last dose of Alectinib (Alecensa) in Combination with Nivolumab (Opdivo).

Who cannot join

  • Intolerant or severe allergic reactions to Alectinib (Alecensa) or Nivolumab (Opdivo)
  • Symptomatic central nervous system metastases. Brain metastases that have previously been treated and are stable for 4 weeks before the first dose date are allowed.
  • Prior treatment with Alectinib (Alecensa) and/or Nivolumab (Opdivo), or prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) for any reason.
  • Locoregional HCC therapy (e.g., TACE, RFA), systemic chemotherapy, hormonal therapy (e.g., tamoxifen) or investigational therapy within 4 weeks (or 5 half-lives, whichever is shorter) prior to Screening.
  • Life expectancy of less than 12 weeks
  • Major surgery or significant trauma within 14 days prior to Screening. Minor surgery within 7 days prior to Screening (excluding the placement of central/peripheral lines or skin biopsy).
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  • Not recovered from the acute toxic effects of prior anticancer therapy, radiation or major surgery/significant trauma at Screening.
  • Major systemic diseases that the investigator considers inappropriate for participation
  • Known human immunodeficiency virus (HIV) infection
  • Concurrent active second malignancy for which the subject is receiving therapy, excluding non-melanomatous skin cancer, non-progressive prostate cancer treated with hormonal therapy, or carcinoma in situ of the cervix. Any cancer curatively treated >5 years prior to entry is permitted.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection (e.g., tuberculosis) requiring antibiotic, antifungal, or antiviral therapy (other than antiHBV therapy), symptomatic heart failure, cardiac arrhythmia, acute or chronic pancreatitis or psychiatric illness/social situations that would limit compliance with study requirementsCNS metastasis.
  • Any active autoimmune disease or history of known autoimmune disease except for vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Ongoing other concurrent investigational agents or anticancer therapy
  • Radiotherapy within 28 days prior to initiation of study treatment, except for palliative radiotherapy to bone lesions. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
  • Presence of central nervous system (CNS) or leptomeningeal metastases. Patients with a history of CNS metastases are eligible for the study if he/she have received radiotherapy or surgery for the CNS metastases, and complete response (no evidence of residual CNS metastases) must be documented by brain CT scan at screening.
  • Requirement of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Prior organ allograft or allogeneic bone marrow transplantation.
  • Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • CMUH

    Taichung

Other trials in Taiwan

About this study

Official title: A Pilot Study of Alectinib (Alecensa) in Combination With Nivolumab (Opdivo) in the Treatment of Recurrent or Refractory Hepatocellular Carcinoma Patients Guided With Serum Level of RNase1 and Tumor Expression of PD-L1

Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death and the second most deadly malignancy in Taiwan. Despite decades' intensive studies, surgery and local-regional chemo-embolization, radio-frequency ablation or radiation therapy remain the mainstay of HCC treatments.

Read the detailed description

For HCC that are not resectable and not amenable to loco-regional therapies, the tyrosine kinase inhibitors (TKIs) sorafenib and its derivative regorafenib, lenvatinib and caboxantinib are of the standard systemic therapy. However, on average only marginal improvement of overall survival has been achieved with significant variation in response to TKI among patients. Effective predictive biomarkers to stratify patients for effective treatments have yet to be discovered.

In recent researches, the investigators have found RNase1 was highly expressed in nivolumab non-response HCC patients, and human ribonuclease1 (RNase1) secreted by tumor cells, was positive correlated with PD-L1 level in HCC patients. Notably, the investigators also found RNase1 regulates macrophage polarization and promotes immunosuppression in immunotherapy by activating ALK signaling in macrophage. the investigators showed that RNase1-overexpressing tumors were sensitive to ALK inhibitor and anti-PD-1 combinational therapy in HCC orthotopic mouse model.

Thus the investigators hypothesize that RNase1 is a potential biomarker for ALK inhibitor and anti-PD-1 combinational therapy in HCC. HCC patients who fit into the criteria would be benefit from ALK inhibitor (alectinib) and anti-PD-1 agent (nivolumab) combinational therapy. To test the role of circulatory RNase1 as a predictive biomarker for responsiveness to ALK inhibitor (alectinib) and anti-PD-1 agent (nivolumab) combinational therapy in Recurrent or Refractory HCC patients, the investigators propose the following pilot clinical studies in patients of HCC who failed the standard TKIs treatment. Total 8 evaluable subjects will be included. Participants will receive Alectinib (Alecensa) which has been approved for the treatment of ALK(+) NSCLC,ROS-1(+) NSCLC; and Nivolumab (Opdivo) has been approved for the treatment of several cancer types. Both of Alectinib and Nivolumab have also been under the reimbursement policy of Taiwan NHIA.

Being tested
Alectinib (Alecensa), Nivolumab (Opdivo)
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Alectinib (Alecensa), Nivolumab (Opdivo)Drug

    Also called Alectinib (Alecensa)+ Nivolumab (Opdivo)

    Alectinib (Alecensa) in Combination with Nivolumab (Opdivo)

Study groups in NCT06354387
Study groupRoleWhat they receive
single armExperimentalopen label
Receives: Drug: Alectinib (Alecensa), Nivolumab (Opdivo)

What is being measured

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

  1. Objective response rate(ORR)

    complete or partial response, as determined by the investigator according to RECIST v1.1

    Measured: Baseline to EOT (up to 52 weeks)

Secondary outcomes (1)

  1. PFS

    Progression-free survival

    Measured: Baseline to long term follow up (up to 52weeks)

Timeline

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

  1. First posted9 Apr 2024
  2. Study start16 Feb 2022
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06354387
Sponsor's protocol ID
CMUH110-REC3-246
Status last verified
Mar 2026
First submitted
18 Mar 2024
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
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 1 study testing Alectinib (Alecensa), Nivolumab (Opdivo) in people with Hepatocellular Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.

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 14 inclusion and 19 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 19 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 Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: Baseline to EOT (up to 52 weeks)). 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 NCT06354387.

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 19 Mar 2026.

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