AzTrials
AzTrials

Metastatic Hepatocellular CarcinomaPhase 1/2NCT03893695

Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma(HCC)

A Phase 1/2 study testing GT90001 and Nivolumab in people with Metastatic Hepatocellular Carcinoma and HCC, run by Suzhou Kintor Pharmaceutical Inc, at 3 sites in Taiwan.

Completed

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

Official record
Search all trials

Trial summary

This single arm, open label, two stage study will be conducted in several medical centers around Taiwan. Stage one determine safety and tolerability in patients with HCC, and stage two assess anti-tumor activities of GT90001 in combination with nivolumab in patients with metastatic HCC. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
GT90001 and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesTaiwan
Study dates
25 May 2019to 27 Sep 2022
Phase
Phase 1/2
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the trial;
  • Age ≥20 years male and female;
  • Subjects must have confirmed diagnosis of unresectable HCC with any of following criteria:
  • Histologically or cytologically confirmed diagnosis of HCC ii. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy;
  • Have documented disease progression or intolerance after first-line systemic treatment;
  • At least one measurable lesion based on RECIST version 1.1 ;
Show all 21Show fewer
  • Child-Pugh score ≤ 6 (Child-Pugh A)score within 7 days of first dose of study drug;
  • ECOG performance status: 0-1;
  • Have a predicted life expectancy of greater than 3 months;
  • The functions of the important organs are confirmed with the following requirement:
  • Hemoglobin (HGB) ≥ 90 g/L;
  • White blood cell count (WBC) ≥ 3×10^9/L；
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L；
  • Platelets (PLT) ≥ 100×10^9/L；
  • Total bilirubin (TBIL) ≤ 1.5× Upper limit of normal value (ULN)
  • Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) ≤ 5× ULN
  • Creatinine (Cr) ≤ 1.5×ULN；
  • International normalization ratio (INR)or prothrombin time (PT) ≤ 1.5×ULN ;
  • Women must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product;
  • Women of childbearing potential must agree to contraception for the duration of study treatment and 5 months after the last dose of study treatment;
  • Willing and able to comply with all aspects of the protocol

Who cannot join

  • Imaging findings for HCC corresponding to any of the following:
  • HCC with ≥ 50% liver occupation
  • Clear invasion into the bile duct
  • Portal vein invasion or thrombosis at the main portal branch (Vp4)
  • Gastric or esophageal varices that require treatment;
  • If prior history of DVT/PE, the patient needs to be on stable doses of anticoagulation with low molecular weight heparin or oral anticoagulant for at least two weeks;
Show all 22Show fewer
  • Esophageal vein dilation, grade A of active peptic ulcer rating, and all bleeding risk by gastroscopy;
  • History of arterial thromboembolic event in past 6 months;
  • Active bleeding disorder, including gastrointestinal bleeding event or active hemoptysis within 28 days prior to study treatment;
  • Have central nervous system (CNS) metastases;
  • Has a known history of human immunodeficiency virus (HIV);
  • Has received prior immune checkpoint inhibitor (including those targeting PD-1, PD-L1 or PD-L2, CD137, or cytotoxic T-lymphocyte antigen [CTLA-4]);
  • Has a known history of, or any evidence of, interstitial lung disease or active non- infectious pneumonitis;
  • Has active autoimmune disease that has required systemic treatment in past 2 years;
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
  • Any history of drug or alcohol dependency or abuse within the prior 1 years;
  • Has known active Hepatitis B or Hepatitis C within 2 weeks prior to initiation of study treatment Note: Patients with HBV infection are required to be receiving effective antiviral therapy over two weeks, and then have continuous therapy in study period;
  • Pregnant, breast feeding, or planning to become pregnant;
  • Have a history of severe hypersensitivity reaction to monoclonal antibody;
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug;
  • Have surgery, radiotherapy, ablation within one month before screening;
  • Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan

  • MacKay Memorial Hospital

    Taipei

  • National TaiWan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma

This single arm, open label, two stage study will be conducted in several medical centers around Taiwan. Stage one determine safety and tolerability in patients with HCC, and stage two assess anti-tumor activities of GT90001 in combination with nivolumab in patients with metastatic HCC. Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study.

Read the detailed description

Based on published and first-hand experience with the safety and tolerability of both GT90001 and nivolumab, the proposed dose is GT90001 7 mg/kg in combination with nivolumb 3 mg/kg. Nivolumab will first be administered by intravenous infusion over 60 minutes, then 30 minutes later, give GT90001 intravenous infusion for 1 hour. All participants will receive GT90001 + Nivolumab until unacceptable toxicity, disease progression or loss of clinical benefit as determined by the investigator.The primary objective of the study is to determine the safety and tolerability of GT90001 in combination with nivolumab in subjects with advanced and or metastatic HCC who were progressed on or were intolerant of first-line and/or second-line systemic therapy. The secondary objectives will be to evaluate the anti-tumor efficacy and the PK profile of this combination therapy.

Being tested
GT90001 and Nivolumab
Keywords
Phase Ib/II, HCC, Metastatic Hepatocellular Carcinoma
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • GT90001 and NivolumabDrug

    Also called GT90001 and Opdivo

    Stage1:Dose de-escalation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.

Study groups in NCT03893695
Study groupRoleWhat they receive
metastatic HCCExperimentalStage one - Dose de-escalation: Each dose cohort will assess toxicity within the 28 days following the first dose of nivolumab and GT90001. Stage two- the expansion cohort: 14 patients will be enrolled to the expansion cohort where one or no DLT takes place in planned study cohort.
Receives: Drug: GT90001 and Nivolumab

What is being measured

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

  1. Dose-limiting Toxicity(DLT)

    Each dose cohort will initially include 6 evaluable patients for assessment of toxicity within the 28 days following the first dose of nivolumab and GT90001.

    Measured: 28 days

Secondary outcomes (15)

  1. overall response rate (ORR)

    To estimate ORR, per RECIST 1.1 assessed by investigator review

    Measured: 2 years

  2. the duration of response (DOR),

    To evaluate the DOR per RECIST 1.1 assessed by investigator review

    Measured: 2 years

  3. disease control rate (DCR),

    To evaluate the DCR per RECIST 1.1 assessed by investigator review

    Measured: 2 years

  4. time to response (TTR)

    To evaluate the TTR per RECIST 1.1 assessed by investigator review

    Measured: 2 years

  5. progression-free survival (PFS)

    To evaluate the PFS per RECIST 1.1 assessed by investigator review

    Measured: 2 years

  6. maximum concentration (Cmax)

    Pharmacokinetics

    Measured: 2 years

  7. time that maximum concentration is observed (tmax)

    Pharmacokinetics

    Measured: 2 years

  8. area under the concentration time-curve from time zero to infinity (AUC0∞)

    Pharmacokinetics

    Measured: 2 years

  9. area under the plasma concentration-time curve from time zero hours to time (t hrs), (AUC0-t)

    Pharmacokinetics

    Measured: 2 years

  10. area under the plasma concentration-time curve from time zero hours to 24 hours (AUC0-24)

    Pharmacokinetics

    Measured: 2 years

  11. terminal elimination rate constant (λz)

    Pharmacokinetics

    Measured: 2 years

  12. terminal elimination half life (t½)

    Pharmacokinetics

    Measured: 2 years

  13. volume of distribution (Vz)

    Pharmacokinetics

    Measured: 2 years

  14. volume of plasma cleared of the drug per unit time (C)

    Pharmacokinetics

    Measured: 2 years

  15. Exploratory Biomarker: circulating tumor deoxyribonucleic acid (ctDNA)

    HCC-related pathway alterations including VEGF and TGF-β pathway genes

    Measured: 2 years

Timeline

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

  1. First posted28 Mar 2019
  2. Study start25 May 2019
  3. Primary completion26 May 2022
  4. Study completion27 Sep 2022

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm, Open label,Two stage study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893695
Sponsor's protocol ID
GT90001-TW-1001
Status last verified
Feb 2024
First submitted
21 Mar 2019
Last updated
9 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hsu C, Chang YF, Yen CJ, Xu YW, Dong M, Tong YZ. Combination of GT90001 and nivolumab in patients with advanced hepatocellular carcinoma: a multicenter, single-arm, phase 1b/2 study. BMC Med. 2023 Oct 20;21(1):395. doi: 10.1186/s12916-023-03098-w.

    PubMed 37858184

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GT90001 and Nivolumab in people with Metastatic Hepatocellular Carcinoma and HCC, run by Suzhou Kintor Pharmaceutical Inc, at 3 sites 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 21 inclusion and 22 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 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined 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.

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?

Dose-limiting Toxicity(DLT) (time frame: 28 days). 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 NCT03893695, 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 9 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in