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Hepatocellular CarcinomaPhase 2NCT05029973

HAIC Combined With Sintilimab and Bevacizumab Biosimilar for Unresectable HCC

A Phase 2 study testing HAIC, Sintilimab and Bevacizumab Biosimilar in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To Evaluate the Efficacy and Safety of the Hepatic Arterial Infusion Chemotherapy(HAIC) Combined With Sintilimab and Bevacizumab Biosimilar in the Treatment of Patients With Unresectable Hepatocellular Carcinoma. 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?
HAIC, Sintilimab and Bevacizumab Biosimilar
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
10 May 2021to 10 Nov 2023
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

  • Written informed consent should be signed before implementing any trial-related procedures;
  • Age ranges from 18 to 75 years old.
  • CNLC-IIb to IIIb HCC based on the Criteria for diagnosis and treatment of hepatocellular carcinoma (2019 edition)
  • At least ≥ 1 measurable lesions per mRECIST;
  • Child-Pugh grade A or B;
  • ECOG PS scores 0-1;
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  • No prior therapy for HCC.
  • Expected survival time > 6 months;
  • Sufficient organ functions, the subjects need to meet the following laboratory indicators:
  • No blood transfusion, no use of hematopoietic stimulators (including g-csf, gm-csf, EPO and TPO) and infusion of human albumin preparations within 14 days prior to screening:Neutrophil absolute count ≥1.5×10^9/L;Platelet count ≥ 100×10^9/L;Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin > ULN but direct bilirubin ≤ ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥ 60 ml/min;
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN
  • Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, the subjects can also be included in the group in case total T3 (or FT3) and FT4 are within the normal range;
  • Myocardial enzyme spectrum should be within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality is not clinically significant, the subject is also included);
  • Female subjects of childbearing age should receive a urine or serum pregnancy test and the result is negative, 3 days prior to accept the first study drug administration (day 1 of cycle 1). In case the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Meanwhile, voluntary use of appropriate contraceptive methods shall be taken during the observation period and within 8 weeks of the last administration of the study drug; Women of non-bearing age are defined as at least 1 year after menopause, or those who have undergone surgical sterilization or hysterectomy; For males, appropriate contraceptive methods should be taken during the observation period and within 8 weeks after the last dose of the study drug.
  • If there is a risk of pregnancy, all subjects (regardless of male and female) need to adopt contraceptives with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last chemotherapeutic drug administration).

Who cannot join

  • known as Inhibition of fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC；Previous HCC recurrence；Hepatic encephalopathy has been clinically diagnosed in the past 6 months .
  • Autoimmune hepatitis (requiring liver puncture).
  • History of organ transplantation or hepatic encephalopathy.
  • Diffuse hepatoma.
  • Clinical symptoms requiring drainage including pleural effusion, ascites, and pericardial effusion.
  • History of nephropathy or nephrotic syndrome.
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  • Bleeding from a varicose vein in the esophagus or gastric fundus caused by portal hypertension in the past 6 months; Presence of severe (G3) varicose veins identified by endoscopy 3 months prior to initial administration; Evidence of portal hypertension (including imaging findings that the length of the spleen exceeds 10 cm and the platelets lower than 100), with a high risk of hemorrhage assessed by the investigator.
  • Arteriovenous thromboembolic events in the past 6 months, including history of myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis or any other serious thromboembolism. Implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except for those with stable thrombosis after conventional anticoagulation therapy.
  • Severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
  • Acceptance of preventive use of low-dose low-molecular-weight heparin (such as Enoxaparin 40 mg/day), except for vitamin K antagonists (such as warfarin).
  • Requiring long-term medication for the inhibition of platelet function, such as aspirin, dipyridamole or clopidogrel.
  • Uncontrollable hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg after optimized medical treatment, history of critical hypertension or hypertensive encephalopathy.
  • Symptomatic congestive heart failure (New York Heart Association class II-IV), symptomatic or poorly controlled arrhythmia, congenital long QT syndrome history or QTc > 500 ms corrected at screening (calculated using the Fridericia method).
  • History of gastrointestinal perforation and or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohns disease, ulcerative colitis, or long-term chronic diarrhea in the past 6 months.
  • Received major surgery (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks prior to the first administration, except for received tissue biopsy or other minor surgery within 7 days prior to the first administration, venipuncture catheterization for intravenous infusion.
  • Past and present history of lung diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired lung functions.
  • Acute or chronic active hepatitis B or C infection.
  • Active tuberculosis (TB), under anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year prior to the first administration.
  • Infected by human immunodeficiency virus (HIV) and known syphilis infection.
  • Severe infections in active phase or poorly controlled clinically. Severe infection within 4 weeks prior to the first administration.
  • Have used immunosuppressive drugs within 4 weeks before the first dose
  • Received live attenuated vaccines within 4 weeks before the first dose or plan to receive live attenuated vaccines during the study period
  • Received Chinese medicine with anti-tumor indications, or received drugs with immunomodulatory effect within 2 weeks before the first administration
  • Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
  • Allergic to Sintilizumab, Bevacizumab preparations and excipients, or had severe allergic reactions to other monoclonal antibodies in the past
  • Received treatment from other clinical trials within 4 weeks before the first dose
  • Female subjects who are pregnant or breastfeeding
  • Other conditions that the subjects are not suitable to participate in this study according to the judgment of the investigator.

Trial locations and contacts

1 site in 1 country.

Huikai Li, MD contact

862223340123 ext. 3091

lihuikai@tjmuch.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Huikai Li, MD, +862223340123 ext. 3091, lihuikai@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: A Study to Evaluate the Efficacy and Safety of the Hepatic Arterial Infusion Chemotherapy(HAIC) Combined With Sintilimab and Bevacizumab Biosimilar in Unresectable Hepatocellular Carcinoma.

To Evaluate the Efficacy and Safety of the Hepatic Arterial Infusion Chemotherapy(HAIC) Combined With Sintilimab and Bevacizumab Biosimilar in the Treatment of Patients With Unresectable Hepatocellular Carcinoma.

Being tested
HAIC, Sintilimab, Bevacizumab Biosimilar
Keywords
Hepatocellular Carcinoma, Sintilimab, Bevacizumab Biosimilar, HAIC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • HAICDrug

    Also called Hepatic Artery Infusion Chemotherapy, FOLFOX

    hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

  • SintilimabDrug

    Also called IBI308

    200mg IV d1,Q3W

  • Bevacizumab BiosimilarDrug

    Also called IBI305

    7.5mg/kg IV d1,Q3W

Study groups in NCT05029973
Study groupRoleWhat they receive
Treatment GroupExperimentalHAIC Combined With Sintilimab and Bevacizumab Biosimilar
Receives: Drug: HAIC; Drug: Sintilimab; Drug: Bevacizumab Biosimilar

What is being measured

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

  1. Overall response rate ( ORR)

    Defined as proportion of patients who have a best response of CR or PR

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Overall survival (OS)

    Defined as the time from the date of treatment start to the date of death

    Measured: Up to 2 years

  2. Events Free Survival (EFS)

    Defined as the time from enrollment to disease progression, recurrence or death (whichever occurs first)

    Measured: Up to 2 years

  3. Surgical conversion rate

    Defined as the incidence rate of patients that receive surgical resection.

    Measured: Up to 2 years

  4. R0 resection rate of patients who accepted surgical resection

    Defined as the proportion of patients undergoing radical resection to the total patients accepted surgical resection

    Measured: Up to 2 years

  5. Pathological complete response (pCR) rate of patients who accepted surgical resection

    Defined as the proportion of patients whose tumor and lymph node completely disappeared to the total patients accepted surgical resection

    Measured: Up to 2 years

  6. Adverse Events (AEs)

    Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 and complications of surgery

    Measured: Up to 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 posted1 Sep 2021
  2. Study start10 May 2021
  3. Primary completion10 Jan 2022
  4. Study completion10 Nov 2023 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029973
Sponsor's protocol ID
HAICDD
Status last verified
Dec 2022
First submitted
29 Aug 2021
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HAIC, Sintilimab and Bevacizumab Biosimilar in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 18 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huikai Li, MD (862223340123 ext. 3091, lihuikai@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate ( ORR) (time frame: Up to 2 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 NCT05029973.

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 8 Feb 2023.

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