Carcinoma, HepatocellularPhase 1/2NCT03812874
A Study of PTX-9908 Injection for Non-resectable HCC With TACE
A Phase 1/2 study testing PTX-9908 Injection in people with Carcinoma, Hepatocellular, run by TCM Biotech International Corp. at 1 site in Taiwan.
Trial summary
This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular carcinoma following TACE treatment. Phase I (Open-label dose escalation) This study will be an open-label study with an Accelerated Phase and a Standard Phase. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- PTX-9908 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Oct 2020to 14 Aug 2026
- 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
- Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A/B with large or multifocal HCC, no vascular invasion, or extrahepatic spread) with completed TACE procedure in 4 weeks before day 1 of study intervention infusion.
- Recovered from TACE treatment and procedure related toxicities including ALT/AST and bilirubin within normal limit or reference numeric value (reference value is defined as the test value before TACE procedure).
- ECOG (Eastern Cooperative Oncology Group) performance status < 2.
- Have adequate organ and marrow function as defined below:
- Absolute neutrophil count > 1,200/µL
- Hemoglobin > 9 g/dL
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- Platelets > 100,000/µL
- Total bilirubin < 2 X ULN
- Have adequate kidney function as estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73m2
- A negative pregnancy test at screening. This applies to any female patient with childbearing potential.
- Agree to use adequate contraception after signing informed consent form, during the duration of study participation and for at least 4-weeks after completion or withdrawal from the study. This applies to any female patient with childbearing potential and any male patient whose female partner has childbearing potential.
- Acceptable contraceptive methods include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) >=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)
- >=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)
- Anticipated life expectancy of >= 6 months at assessment during screening.
- Ability to understand and have signed a written informed consent document.
Who cannot join
- 1. Patient with Child-Pugh B8-9.
- Patient who has had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the screening visit.
- Patient who has received any other investigational agents within 4 weeks prior to the screening visit.
- Patient who has not recovered from the side effects of the earlier investigational agent or had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy.
- Patient with known brain metastases, leptomeningeal or epidural metastases (unless treated and well controlled for >= 3 months).
- Patient with prior history of co-malignancies, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell/squamous cell skin cancer.
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- Patient with history of myocardial infarction or uncontrolled cardiac dysfunction, or unstable arrhythmia or symptomatic peripheral arterial vascular disease.
- Patient with history of positive serology for human immunodeficiency virus (HIV).
- Patient with active, uncontrolled bacterial, viral, or fungal infections, which require systemic therapy.
- Patient with poor liver function as indicated by serum bilirubin > 2 mg/dL, Child-Pugh Class C, severe coagulopathy (INR > 2) not correctable with vitamin K, or active hepatic encephalopathy.
- Patient with known allergic reactions to biological agent or polypeptides similar to PTX-9908 Injection.
- Woman who is pregnant or nursing.
- Patient with concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.
- Patient with unwillingness or inability to comply with the study protocol for any reason.
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT correction formula
- A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
New Taipei City, Taiwan, 10002
About this study
Official title: Phase I/II Study of PTX-9908 Injection as an Inhibitor of Cancer Progression in Patients With Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment
This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular carcinoma following TACE treatment.
Phase I (Open-label dose escalation)
Read more
This study will be an open-label study with an Accelerated Phase and a Standard Phase. For the Accelerated Phase of the study, one patient per dose level (1 mg/kg, and 2 mg/kg) is planned. For the dose levels in the standard phase (4 mg/kg, 8 mg/kg and 16 mg/kg), it will follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be followed by a 2-week follow-up period.
Phase II (Randomized placebo controlled dose expansion)
The objective of phase II is to further evaluate the safety, tolerability and antitumor activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma following TACE treatment. Approximately 24 eligible patients who have received TACE treatment and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays), and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed by a 2-week follow-up period.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- PTX-9908 Injection, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-9908 InjectionDrug
Proposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg.
Frequency:
Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).
Duration: 4 weeks (Phase I) and 12 weeks (Phase II).
PlaceboDrug
water for injection
Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).
Duration: 12 weeks (Phase II)
| Study group | Role | What they receive |
|---|---|---|
| PTX-9908 Injection group | Experimental | IV injection. Receives: Drug: PTX-9908 Injection |
| Placebo/Vehicle group | Placebo comparator | IV injection Receives: Drug: PTX-9908 Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the number and severity of Adverse Events
Measured: Week 1 - Week 8 (Phase I)/Week 16 (Phase II)
Safety as measured by number of participants with a dose limiting toxicity (DLT)
Any of the following, if judged to be associated with PTX-9908 Injection or the combination of TACE with PTX-9908 Injection (i.e., with possible causality) that occur within the DLT evaluation window, will be considered as a DLT.
- All Grade 4 (i.e., life-threatening) non-hematological and hematological toxicities (except for Grade 4 lymphopenia).
- Grade 3 anemia with clinically significant bleeding
- All grades of febrile neutropenia.
- All Grade 3 non-laboratory/non-hematologic treatment-emergent adverse events, with the exception for nausea, vomiting, or diarrhea that resolves within 3 days.
- Grade 3 thrombocytopenia with clinically significant bleeding is a DLT.
- Grade 3 cytokine release syndrome of any duration is a DLT.
- Grade 3 laboratory adverse events that are judged by the investigator as clinically significant.
Measured: Week 1 - Week 6 (Phase I only)
Secondary outcomes (7)
Recommended Phase 2 Dose (RP2D)
The RP2D was based on the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level, and the assessment of any relevant chronic toxicity.
Measured: Week 1 - Week 6 (Phase I only)
Maximum Plasma Concentration (Cmax) of single-dose and repeat-dose of PTX-9908 Injection
Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of PTX-9908 Injection administered with IV dose derived from plasma concentration versus time data.
Measured: Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II
Terminal Half-life (T-Half) of single-dose and repeat-dose of PTX-9908 Injection
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of PTX-9908 Injection administered with IV.
Measured: Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II
Overall Tumor Response
Number of participants with a best overall tumor response of complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Overall tumor response will be assessed using contrast-enhanced CT imaging according to mRECIST criteria following the 1.1 release of RECIST.
Measured: Week 1 - Week 16 (Phase II)
Response of target hepatic lesions in embolized territory
Number of participants with hepatic lesion in embolized territory of complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Tumor response will be assessed using contrast-enhanced CT imaging according to mRECIST criteria following the 1.1 release of RECIST
Measured: Week 1 - Week 16 (Phase II)
To evaluate overall time-to-progression
Time to progression (TPP) will start from TACE administration to radiological progression. Definition of progression is based on the mRECIST criteria.
Measured: Week 1 - Week 16 (Phase II)
To evaluate change in AFP levels.
Measured: Week 1 - Week 16 (Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start6 Oct 2020
- Primary completion14 Aug 2026
- Study completion14 Aug 2026 (estimated)
Why it stopped: Due to business considerations and challenges in participant recruitment, the Sponsor has decided to discontinue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I: Singe-arm, open-labeled Phase II: Randomized, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCM Biotech International Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chien-Hung Chien-Hung, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812874
- Sponsor's protocol ID
- PTX-9908-HCC-01
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2019
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of PTX-9908 Injection as an Inhibitor of Cancer Progression in Patients With Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment
- ClinicalTrials.gov ID
- NCT03812874
- Acronym / sponsor ID
- PTX-9908-HCC-01
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to business considerations and challenges in participant recruitment, the Sponsor has decided to discontinue the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TCM Biotech International Corp.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular carcinoma following TACE treatment.
Phase I (Open-label dose escalation)
This study will be an open-label study with an Accelerated Phase and a Standard Phase. For the Accelerated Phase of the study, one patient per dose level (1 mg/kg, and 2 mg/kg) is planned. For the dose levels in the standard phase (4 mg/kg, 8 mg/kg and 16 mg/kg), it will follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be followed by a 2-week follow-up period.
Phase II (Randomized placebo controlled dose expansion)
The objective of phase II is to further evaluate the safety, tolerability and antitumor activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma following TACE treatment. Approximately 24 eligible patients who have received TACE treatment and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays), and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed by a 2-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I: Singe-arm, open-labeled Phase II: Randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| PTX-9908 Injection group | Experimental | Drug: PTX-9908 InjectionIV injection. |
| Placebo/Vehicle group | Placebo comparator | Drug: PTX-9908 Injection, Drug: PlaceboIV injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A/B with large or multifocal HCC, no vascular invasion, or extrahepatic spread) with completed TACE procedure in 4 weeks before day 1 of study intervention infusion.
- Recovered from TACE treatment and procedure related toxicities including ALT/AST and bilirubin within normal limit or reference numeric value (reference value is defined as the test value before TACE procedure).
- ECOG (Eastern Cooperative Oncology Group) performance status < 2.
- Have adequate organ and marrow function as defined below:
- Have adequate kidney function as estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73m2
Key exclusion criteria (17 listed)
- 1. Patient with Child-Pugh B8-9.
- Patient who has had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the screening visit.
- Patient who has received any other investigational agents within 4 weeks prior to the screening visit.
- Patient who has not recovered from the side effects of the earlier investigational agent or had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy.
- Patient with known brain metastases, leptomeningeal or epidural metastases (unless treated and well controlled for >= 3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTX-9908 InjectionProposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg. Frequency: Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses). Duration: 4 weeks (Phase I) and 12 weeks (Phase II). | Drug | PTX-9908 Injection group, Placebo/Vehicle group |
| Placebowater for injection Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses). Duration: 12 weeks (Phase II) | Drug | Placebo/Vehicle group |
Primary outcome
Safety as measured by the number and severity of Adverse Events
Time frame: Week 1 - Week 8 (Phase I)/Week 16 (Phase II)
Safety as measured by number of participants with a dose limiting toxicity (DLT)
Time frame: Week 1 - Week 6 (Phase I only)
Any of the following, if judged to be associated with PTX-9908 Injection or the combination of TACE with PTX-9908 Injection (i.e., with possible causality) that occur within the DLT evaluation window, will be considered as a DLT. 1. All Grade 4 (i.e., life-threatening) non-hematological and hematological toxicities (except for Grade 4 lymphopenia). 2. Grade 3 anemia with clinically significant bleeding 3. All grades of febrile neutropenia. 4. All Grade 3 non-laboratory/non-hematologic treatment-emergent adverse events, with the exception for nausea, vomiting, or diarrhea that resolves within 3 days. 5. Grade 3 thrombocytopenia with clinically significant bleeding is a DLT. 6. Grade 3 cytokine release syndrome of any duration is a DLT. 7. Grade 3 laboratory adverse events that are judged by the investigator as clinically significant.
7 secondary outcomes
Recommended Phase 2 Dose (RP2D)
Time frame: Week 1 - Week 6 (Phase I only)
Maximum Plasma Concentration (Cmax) of single-dose and repeat-dose of PTX-9908 Injection
Time frame: Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II
Terminal Half-life (T-Half) of single-dose and repeat-dose of PTX-9908 Injection
Time frame: Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II
Overall Tumor Response
Time frame: Week 1 - Week 16 (Phase II)
Response of target hepatic lesions in embolized territory
Time frame: Week 1 - Week 16 (Phase II)
To evaluate overall time-to-progression
Time frame: Week 1 - Week 16 (Phase II)
To evaluate change in AFP levels.
Time frame: Week 1 - Week 16 (Phase II)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hung Chien-Hung, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PTX-9908 Injection in people with Carcinoma, Hepatocellular, run by TCM Biotech International Corp. 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 18 inclusion and 17 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: withdrawn, as of the sponsor's last update on 2 Oct 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety as measured by the number and severity of Adverse Events (time frame: Week 1 - Week 8 (Phase I)/Week 16 (Phase II)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.