ClinicalTrials.gg
CompletedNCT02112656OPTIMAUpdated Aug 20, 2024Results posted

Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)

A Phase 3 interventional study of ThermoDox and Dummy infusion in Hepatocellular Carcinoma, sponsored by Imunon. Completed at 61 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Imunon · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
554
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,309 studies in Carcinoma, Hepatocellular with a site in China — 485 open to participants now, 557 under way, 70 of them phase 3. Carcinoma, Hepatocellular · China.

Enrollment
64th of 1,033
554 · median 78
Started
2014
with 29 others
Phase 3
169 of 1,309
40 open now
Registered
154th of 1,309
by date

Among the 1,309 studies in Carcinoma, Hepatocellular with a site in China, this one is the 64th largest by enrollment of the 1,033 interventional ones that give a count, is one of 30 that started in 2014, is one of 169 in phase 3, and was the 154th registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

485 of the 1,309 studies in Carcinoma, Hepatocellular with a site in China are open now. Recruiting first, the newest first:

480 more — sign in →

All 485 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized radiofrequency ablation (sRFA).

Read the detailed description

This is a Phase III, randomized, double blind, dummy controlled safety and efficacy study of ThermoDox plus sRFA compared to sRFA plus dummy infusion using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm. An sRFA treatment for this protocol is defined as the dwell time of ≥ 45 minutes measured from the first activation of the RFA probe through removal of the RFA probe after the final ablation cycle or deployment.

The 50 mg/m2 ThermoDox or dummy infusion will be administered IV over 30 minutes. As part of blinded pre-medication ThermoDox treated subjects will receive 20 mg of dexamethasone orally 24 hours prior to the drug infusion for infusion reaction prophylaxis. Subjects on the control arm will receive a matching dummy pre-medication pill orally at 24 hours prior to infusion of the study treatment. Thirty minutes prior to receiving the ThermoDox infusion, subjects will receive a blinded dose of 20 mg of IV dexamethasone, 50 mg IV diphenhydramine and either 50 mg of IV ranitidine or 20 mg of IV famotidine. Subjects on the control arm will receive a masked dummy pre-medication pill orally at 24 hours prior to infusion of the study medication, and a dummy infusion 30 minutes prior to dummy infusion of Sodium Chloride 0.9% or 5% Dextrose (D5W). RFA will be initiated approximately at a minimum of 15 minutes after the initiation of study drug infusion and should be completed no later than 3 hours after study drug infusion initiation. The goal is to reach a > 45 minute dwell time which can be achieved by employing at least four ablation cycles or deployments in order to ablate the tumor as well as a 360º 1.0 cm tumor-free margin surrounding the tumor.with an estimated overall procedure time of less than 3 hours.

A subject who has an incomplete ablation is eligible for 1 retreatment procedure within 21 days after the radiological imaging exam showing residual disease at Day 28. Subjects will be retreated only once with the same RFA equipment and treatment assigned at randomization. Subjects with a complete ablation after retreatment will be followed both for PFS and for OS.

If after 2 ablations the subject has local, distant intrahepatic, or extrahepatic HCC, then the subject will be considered a treatment failure and will have met the PFS endpoint. The subject will be followed for OS every 3 months. Among subjects who are not treatment failures, five repeat treatments are permitted to treat a recurrent lesion or to treat newly-identified local or distant intrahepatic lesions at the Investigator's discretion after the PFS endpoint is reported and with agreement from the Sponsor. The subject must be eligible for retreatment consistent with the safety eligibility criteria and will be retreated with the same randomized treatment.

CT or MRI imaging will be used to assess the effectiveness of the ablation therapy. The blind will be maintained at the level of the imaging reads. Investigator determined radiological progression must be observed and recorded prior to beginning alternate treatments for HCC. Posttreatment imaging will be obtained at months 1, 5, 9, 13, 17, 21, 25, then every 6 months (+/- 2 weeks) until radiological progression is seen. Adverse event assessments and laboratory examinations will occur at each visit. All subjects will be monitored throughout the investigational period.

Patients that meet inclusion/exclusion criteria may be at risk for contrast-induced nephropathy (CIN) when undergoing the required CT with contrast procedures. The investigators must be mindful of the risk factors associated with CIN and employ strategies to reduce the risk of CIN. In subjects with diabetes or borderline renal function (creatinine greater than 1.5 mg/dL) special precautions (e.g. hydration, contrast dose reduction, follow up creatinine determination) should be employed. An accepted procedure is adequate intravenous volume expansion with isotonic saline (1.0 - 1.5 mL/kg per hour) for 3-12 hours before the procedure and continued for 6-24 hours if clinically indicated and based on the treating physician's medical judgment.

All randomized subjects will be followed for safety and overall survival.

03

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Carcinoma
  • Carcinoma, Hepatocellular
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • Neoplasms
  • Adenocarcinoma
  • Liver Neoplasms
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Digestive System Diseases
  • Liver Diseases
  • Doxorubicin
  • Antibiotics, Antineoplastic
  • Antineoplastic Agents
  • Therapeutic Uses
  • Pharmacologic Actions
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female ≥ 18 years of age.
  2. Diagnosed with a single HCC lesion ≥ 3.0 cm but ≤ 7.0 cm in maximum diameter based on diagnosis at screening.

    • Subjects meeting the American Association for the Study of Liver Disease (AASLD) criteria may be randomized without a , but will undergo a biopsy during the RFA procedure unless or unattainable.
    • Subjects not meeting the AASLD criteria for HCC will need a biopsy to confirm HCC prior to randomization.
  3. Be an appropriate candidate for receiving RFA as a medically indicated treatment as evaluated by the following factors:

    • The position and accessibility of the target lesion allows for the safe administration of multiple ablation cycles or deployments to achieve a probe dwell time of ≥ 45 minutes.
    • Not a candidate for surgical resection according to the local guidelines for resection and in the Investigator's judgment.
  4. Class A without either current encephalopathy or ascites.
  5. (LVEF) ≥ 50%.
  6. (ECOG) performance status 0.
  7. Willing to sign an form, indicating awareness of the nature of this study that is in keeping with the policies of the institution.

Exclusion criteria

Exclusion Criteria:

  1. Is scheduled for liver transplantation
  2. Expected ablation volume > 30% of total liver volume or removal of 3 hepatic segments
  3. More than 1 lesion identified during baseline.
  4. Have previously received therapeutic treatment for HCC outside the study protocol or is expected to receive concomitant HCC treatment prior to PFS event.
  5. Have serious medical illnesses including, but not limited to, congestive heart failure, myocardial infarction or cerebral vascular accident within the last six months, or life threatening cardiac arrhythmias.
  6. Have previously received any anthracycline outside the protocol
  7. Have extrahepatic .
  8. Have portal or hepatic vein tumor invasion/thrombosis.
  9. Have body temperature >101ºF (38.3ºC) immediately prior to study treatment.
  10. Baseline laboratories (repeat lab tests are permitted to evaluate eligibility during the Screening Period. Lab results must be within protocol range prior to study treatment.)

    • \< 1500/mm3
    • count \< 75,000/mm3
    • \< 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic and judged able to withstand the RFA procedure) Note: If clinically indicated, subjects may receive platelets or packed red blood cell (RBC) transfusions and be re-evaluated after condition is treated.
  11. Baseline Chemistry

    • Serum creatinine ≥ 2.5 mg/dL or calculated (CrCl) ≤25.0 mL/min.
    • Serum > 3.0 mg/dL.
    • Serum albumin \< 2.8 g/dL.
  12. Have any known allergic reactions to any of the drugs or liposomal components or intravenous imaging agents that prohibit the ability to complete the imaging requirements.
  13. Are pregnant or breast-feeding. In women of , a negative serum pregnancy test is required prior to study treatment.
  14. Women of childbearing potential and men who are not practicing an acceptable form of (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has or men who have undergone a vasectomy must use a second form of birth control).
  15. Have > 1.5 times the institution's upper normal limit (UNL), except in subjects who are therapeutically anticoagulated for medical conditions unrelated to HCC such as atrial fibrillation. Subjects may be re-screened after condition is treated or anticoagulant is withheld.
  16. Have to receiving doxorubicin hydrochloride (HCl).
  17. Are being treated with other agents.
  18. Use of an investigational drug outside this study within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
  19. Have other concurrent (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.
  20. positive.
  21. class III or IV functional classification for heart failure.
  22. Evidence of hemachromatosis.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
554 participants (actual)

Study arms

  • Experimental
    ThermoDox 50 mg/m2

    ThermoDox plus standardized RFA using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm

    Drug: ThermoDox

  • Placebo comparator
    Dummy infusion

    standardized RFA alone using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm

    Drug: Dummy infusion

Interventions

  • Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion

    Also known as: Lyso-Thermosensitive Liposomal Doxorubicin (LTLD)

  • DrugDummy infusion

    Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Overall survival is defined as the time (in months) from the date of randomization to the death from any cause or the end of the study.

    Time frame: All subjects to be contacted every 3 months after radiological progression for vital status reporting. Subjects were followed for OS up to 68 months from randomization.

Secondary outcomes

  1. Progression-free Survival (PFS)

    The protocol incorporates modified RECIST developed for HCC clinical research as a basis to evaluate tumor response. PFS here is defined as the time (in months) from the date of randomization to the first date on which one of the following occurs (as determined by CT or MRI scan): * Death of any cause * Treatment failure (inability to achieve CR after two RFA ± ThermoDox treatment sessions) * Progression due to local tumor recurrence after initial CR * Progression due to distant intrahepatic tumor recurrence * Progression due to extrahepatic tumor recurrence

    Time frame: CT or MRI scan (Chest, Abdomen, Pelvis) done at Baseline and Day 28. Additional imaging done at months 5, 9, 13, 17, 21, 25, then every 6 months until disease progression is seen. Study subjects were followed up to 63 months after randomization.

07

Results

Posted Aug 20, 2024

Participant flow

Participant flow — Overall Study
MilestoneThermoDox 50 mg/m2Dummy Infusion
Started277277
Completed187178
Not completed9099
Withdrew: Death7882
Withdrew: Withdrawal by subject911
Withdrew: Lost to follow-up24
Withdrew: Noncompliance12

Outcome measures

PrimaryOverall Survival (OS)

Overall survival is defined as the time (in months) from the date of randomization to the death from any cause or the end of the study.

Time frame:
All subjects to be contacted every 3 months after radiological progression for vital status reporting. Subjects were followed for OS up to 68 months from randomization.
Reported as:
Median · Months
Overall Survival (OS)
MonthsThermoDox 50 mg/m2Dummy Infusion
Overall Survival (OS)58.06 (45.53 to NA)NA (47.93 to NA)
SecondaryProgression-free Survival (PFS)

The protocol incorporates modified RECIST developed for HCC clinical research as a basis to evaluate tumor response. PFS here is defined as the time (in months) from the date of randomization to the first date on which one of the following occurs (as determined by CT or MRI scan): * Death of any cause * Treatment failure (inability to achieve CR after two RFA ± ThermoDox treatment sessions) * Progression due to local tumor recurrence after initial CR * Progression due to distant intrahepatic tumor recurrence * Progression due to extrahepatic tumor recurrence

Time frame:
CT or MRI scan (Chest, Abdomen, Pelvis) done at Baseline and Day 28. Additional imaging done at months 5, 9, 13, 17, 21, 25, then every 6 months until disease progression is seen. Study subjects were followed up to 63 months after randomization.
Reported as:
Median · Months
Progression-free Survival (PFS)
MonthsThermoDox 50 mg/m2Dummy Infusion
Progression-free Survival (PFS)19.31 (15.72 to 25.20)16.78 (12.86 to 21.32)

Adverse events

Collected over Assess adverse events (AEs) through Day 28 following study treatment. AEs after Day 28 evaluated as possibly, probably or definitely related to the study treatment or the RFA procedure were recorded at any point during the trial and are to be followed until resolution or the patient is clinically stable. In general, all subjects were followed up to 68 months for AE's.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ThermoDox 50 mg/m278/277 (28.2%)73/274 (26.6%)265/274 (96.7%)
Dummy Infusion82/277 (29.6%)33/273 (12.1%)216/273 (79.1%)
Most frequent serious events
Showing 10 of 83
Most frequent serious events
EventThermoDox 50 mg/m2Dummy Infusion
NeutropeniaBlood and lymphatic system disorders21/2741/273
Febrile NeutropeniaBlood and lymphatic system disorders11/2740/273
PyrexiaGeneral disorders2/2746/273
Pleural EffusionRespiratory, thoracic and mediastinal disorders0/2744/273
PneumoniaInfections and infestations4/2743/273
Neutrophil Count DecreasedInvestigations4/2740/273
White Blood Cell Count DecreasedInvestigations3/2740/273
Liver AbscessInfections and infestations2/2742/273
SepsisInfections and infestations2/2742/273
Alanine Aminotransferase IncreasedInvestigations0/2742/273
Most frequent other events
Showing 10 of 349
Most frequent other events
EventThermoDox 50 mg/m2Dummy Infusion
AlopeciaSkin and subcutaneous tissue disorders142/2741/273
NeutropeniaBlood and lymphatic system disorders136/2745/273
Neutrophil Count DecreasedInvestigations73/2744/273
White Blood Cell Count DecreasedInvestigations66/2743/273
Aspartate Aminotransferase IncreasedInvestigations35/27458/273
PyrexiaGeneral disorders28/27452/273
Alanine Aminotransferase IncreasedInvestigations36/27445/273
Abdominal PainGastrointestinal disorders28/27444/273
Abdominal Pain UpperGastrointestinal disorders39/27439/273
Procedural PainInjury, poisoning and procedural complications22/27428/273

Baseline characteristics

Baseline participants represent the intent-to-treat (ITT) population.

Age, Continuous
Age, Continuous(years)ThermoDox 50 mg/m2Dummy InfusionTotal
Median62 (28 to 86)62 (36 to 90)62 (28 to 90)
Sex: Female, Male
Sex: Female, Male(Participants)ThermoDox 50 mg/m2Dummy InfusionTotal
Female5465119
Male223212435
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ThermoDox 50 mg/m2Dummy InfusionTotal
American Indian or Alaska Native000
Asian265257522
Native Hawaiian or Other Pacific Islander000
Black or African American000
White121931
More than one race011
Unknown or Not Reported000
08

Study locations

61 sites
  • UCLA Department of Medicine
    Los Angeles, California 90095, United States
  • Toronto General Hospital
    Toronto, Ontario, Canada
  • Mengchao Hepatobiliary Hospital of Fujian Medicatl University
    Fuzhou, Fujian 350005, China
  • Xijing Hospital
    Xi'an, Shaanxi 710032, China
  • Peking University First Hospital
    Beijing, 100034, China
  • Beijing Cancer Hospital, School of Oncology, Peking
    Beijing, 100036, China
  • 302 Military Hospital of China
    Beijing, 100039, China
  • Beijing Hospital of the Ministry of Health
    Beijing, 100730, China
  • Chinese PLA General Hospital
    Beijing, China
  • West China Hospital of Sichuan University
    Chengdu, 610041, China
  • The Second Hospital of Dalian Medical University
    Dalian, 116023, China
  • Guangdong General Hospital
    Guangdong, 510080, China
  • Hunan Cancer Hospital
    Hunan, 410013, China
  • The First Hospital of Jilin University
    Jilin, 130021, China
  • Zhongshan Hospital, Fudan University
    Shanghai, 200032, China
  • The Sixth People's Hospital of Shenyang
    Shenyang, 110006, China
  • The 3rd Hospital of Tianjing
    Tianjin, 300170, China
  • The First Hospital of Zhejiang
    ZheJiang, 310013, China
  • Zhejiang Cancer Hospital
    Zhejiang, 310022, China
  • Institut für Diagnostische und Radiologische Therapie del Uniklinik Frankfurt
    Frankfurt, Germany
  • Universitaetsklinikum des Saarlandes, Klik fuer Allgemeine Chirurgie, Viszeral-, Gefaess und Kinderchirurgie
    Homburg, 66421, Germany
  • Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik (Gastroenterologie)
    München, Germany
  • Universitätsklinikum Regensburg, Institut für Röntgendiagnostik
    Regensburg, Germany
  • Queen Mary Hospital
    Hong Kong, Hong Kong
  • Cisanello Hospital, Division of Diagnostic Imaging and Intervention
    Pisa, Italy
  • Department of Radiological Sciences and Bioimaging Catholic University of Rome, "A. Gemelli" Hospital
    Rome, Italy
  • Pusan National University Hospital
    Busan, 602-739, Korea, Republic of
  • Kyungpook National University Hospital
    Daegu, 700-721, Korea, Republic of
  • Kyungpook National University Medical Center
    Daegu, 702-210, Korea, Republic of
  • Inha University Hospital
    Incheon, 400-711, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, 120-752, Korea, Republic of
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
  • The Catholic University of Korea, Seoul St.Mary's Hospital
    Seoul, 137-701, Korea, Republic of
  • University Malaya Medical Centre
    Kuala Lumpur, 59100, Malaysia
  • Chinese General Hospital and Medical Center
    Manila, 1003, Philippines
  • St. Lukes Medical Center
    Quezon City, 1112, Philippines
  • Cardinal Santos Medical Center
    San Juan, 1503, Philippines
  • Singapore General Hospital
    Singapore, 169608, Singapore
  • Hospital Madrid Norte Sanchinarro
    Madrid, Spain
  • Hospital Universitario Marqués de Valdecilla
    Santander, Spain
  • Chang Gung Memorial Hospital - Kaohsiung
    Kaohsiung, 833, Taiwan
  • Taipei Medical University-Shuang Ho Hospital
    New Taipei City, 235, Taiwan
  • Taichung Veteran General Hospital
    Taichung, 407, Taiwan
  • National Cheng Kung University (NCKU) Hospital
    Tainan, 704, Taiwan
  • National Taiwan University Hospital
    Taipei City, 100, Taiwan
  • Chang Gung Memorial Hospital - Linkou
    Taoyuan, 333, Taiwan
  • National Taiwan University Hospital, Yun-Lin Branch
    Yuanlin, 640, Taiwan
  • Siriraj Hospital
    Bangkok, 10700, Thailand
  • Maharaj Nakorn Chiang Mai Hospital
    Chiang Mai, Thailand
  • Srinagarind Hospital
    Khon Kaen, 40002, Thailand
  • Thammasat University Hospital
    Pathumthani, 12120, Thailand
  • Songklanagarind Hospital
    Songkhla, 90110, Thailand
  • Bach Mai Hospital
    Hà Nội, Dong Da District, Vietnam
  • 108 Military Central Hospital
    Hà Nội, Hai Ba Trung District, Vietnam
  • Hue Central Hospital
    Huế, Vin Ninh Ward, Vietnam
  • Bach Mai Hospital (Hepato-gastroenterology Department)
    Hanoi, Vietnam
  • Can Tho Oncology Hospital
    Hanoi, Vietnam
  • National Cancer Hospital
    Hanoi, Vietnam
  • Viet Duc University Hospital
    Hanoi, Vietnam
  • People's Hospital 115
    Ho Chi Minh City, Vietnam
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Apr 2020 and a completion of Apr 2020. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2024, 4 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2014
First posted
Apr 14, 2014
Start
Jun 2014
Primary completionActual
Apr 27, 2020
CompletionActual
Apr 27, 2020
Results first posted
Aug 20, 2024
Last update
Aug 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02112656
Lead sponsor
Imunon
Responsible party
Sponsor
First posted
Apr 14, 2014
Start date
Jun 2014
Primary completion
Apr 27, 2020
Completion
Apr 27, 2020
Results posted
Aug 20, 2024
Last update
Aug 20, 2024

Study contacts

Ricardo Lencioni, MD
study chair · University of Pisa
Ronnie Tung Ping Poon, MD
study chair · Hong Kong University
Chen Min Hua, MD
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lyso-Thermosensitive Liposome Doxorubicin

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