AzTrials
AzTrials

Hepatocellular CarcinomaPhase 1/2NCT04843943

Sintilimab Combined With Bevacizumab Biosimilar for Potentially Resectable Intermediate HCC

A Phase 1/2 study testing Sintilimab and Bevacizumab Biosimilar in people with Hepatocellular Carcinoma, run by Fudan University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This is a Phase Ib study to evaluate the safety and efficacy of sintilimab combined with bevacizumab biosimilar in patients with potentially resectable intermediate hepatocellular carcinoma (HCC). 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?
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
No sites listed yet
Study dates
1 May 2021to 1 May 2023
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide informed consent and willing to sign an approved consent form
  • Age 18-75, male and female
  • Potentially resectable Intermediate (CNLC-IIa and IIb) HCC with diagnosis confirmed by histology/cytology or clinically
  • No prior therapy for HCC
  • Child-Pugh: A
  • ECOG PS: 0-1
Show all 11Show fewer
  • Expected survival ≥6 months
  • Measurable disease per RECIST1.1
  • Major organ functions meet the following requirements:
  • 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 ≥1.0×10^9/L;Platelet count ≥ 75×10^9/L;Hemoglobin ≥ 9 g/dL;Serum albumin ≥ 2.8 g/dL;Total serum bilirubin ≤2.0× upper limit of normal range (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;Serum creatinine (Cr) ≤1.5×ULN or Cr clearance ≥30 mL/min (calculated by Cockcroft-Gault formula);International standardized ratio (INR) ≤1.5×ULN;
  • Women of childbearing age must undergo a blood pregnancy test within the first 3 days of randomization with negative results and agree to use a reliable and effective method of contraception during the trial and within 120 days of the last trial drug administration. Male patients whose partners are women of childbearing age must agree to use a reliable and effective method of contraception during the trial and within 120 days of the last trial drug administration.

Who cannot join

  • known as cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and hepatic fibrolamellar carcinoma.
  • History of organ transplantation or hepatic encephalopathy
  • Tumor accumulation range exceeds 70% of liver volume
  • Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage
  • Any history of kidney disease or nephrotic syndrome
  • History of gastrointestinal (GI) perforation and/or fistula in the past 6 months;Severe (G3) varicose veins are known to be present on endoscopy within 3 months before the first dose ; history of thrombosis, bleeding diathesis, coagulopathy or significant vascular disease
Show all 27Show fewer
  • Prior life-threatening blood loss or grade 3/4 gastrointestinal bleeding requiring blood infusion, endoscopic or surgical intervention within 3 months
  • Arterial and venous thromboembolic events in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism history.
  • Severe bleeding tendency or coagulopathy, or are receiving thrombolytic therapy
  • Long-term use of vitamin K antagonists (such as warfarin) or low-dose low-molecular-weight heparin (such as enoxaparin 40 mg/day) or heparin
  • Uncontrollable hypertension, systolic blood pressure> 140 mmHg or diastolic blood pressure> 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy
  • Symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or QTc> 500ms corrected during screening
  • History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months of initiation of study treatment
  • Had major surgical procedure within 4 weeks of initiation of study treatment
  • Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases
  • Had acute or chronic active hepatitis B or C infection. Hepatitis C virus (HCV) RNA>103 copies/ml; hepatitis B surface antigen (HbsAg) and anti-HCV antibody are positive at the same time; hepatitis B virus (HBV) DNA positive but has received antiviral treatment is allowed.
  • Had active tuberculosis (TB)
  • Had human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection
  • Had severe infections that are active or poorly clinically controlled.
  • Had active autoimmune disease
  • 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 patients who are pregnant or breastfeeding

Trial locations and contacts

No sites are listed yet.

Huichuan Sun contact

13701922065

sun.huichuan@zs-hospital.sh.cn

About this study

Official title: An Exploratory Study of Sintilimab in Combination With Bevacizumab Biosimilar in Patients With Potentially Resectable Intermediate HCC

This is a Phase Ib study to evaluate the safety and efficacy of sintilimab combined with bevacizumab biosimilar in patients with potentially resectable intermediate hepatocellular carcinoma (HCC).

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

What participants receive

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

  • SintilimabDrug

    Sintilimab: 200mg IV Q3W D1

  • Bevacizumab BiosimilarDrug

    Bevacizumab biosimilar: 15mg/kg, IV, Q3W, D1

Study groups in NCT04843943
Study groupRoleWhat they receive
Sintilimab+BevacizumabExperimentalNot described
Receives: Drug: Sintilimab; Drug: Bevacizumab Biosimilar

What is being measured

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

  1. 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; Surgical safety including Intraoperative blood loss，PHLF assessed by ISGLS（2012），Postoperative complications evaluated by modified Clavien-Dindo system

    Measured: Up to 2 years

  2. Events Free Survival (EFS) Assessed by RECIST1.1

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

    Measured: Up to 2 years

Secondary outcomes (8)

  1. resection rate (R0 resection rate)

    Defined as the proportion of patients undergoing radical resection to the total subjects (R0 resection rate)

    Measured: Up to 2 years

  2. Pathological response rate

    Defined as the proportion of patients who had pathological response.

    Measured: Up to 2 years

  3. Objective response rate (ORR) assessed by RECIST1.1

    Defined as the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

    Measured: Up to 2 years

  4. Recurrence-free survival (RFS) of patients who accepted surgery

    Defined as the time from the date of surgery to the date of disease recurrence or death whichever occur first, assessed up to 2 years post-treatment

    Measured: Up to 2 years

  5. Progression free survival (PFS) assessed by RECIST1.1 of patients who didn't accept surgery

    Defined as the time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

    Measured: Up to 2 years

  6. Overall survival (OS) of the patients who accepted surgery

    Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive.

    Measured: Up to 2 years

  7. Overall survival (OS) of the patients who didn't accepted surgery

    Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive.

    Measured: Up to 2 years

  8. Overall survival (OS)

    Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive

    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 posted14 Apr 2021
  2. Study start1 May 2021 (estimated)
  3. Primary completion1 May 2022 (estimated)
  4. Study completion1 May 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 1/2
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
NCT04843943
Sponsor's protocol ID
B2020-156(2)R
Status last verified
Apr 2021
First submitted
8 Apr 2021
Last updated
14 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun HC, Zhu XD, Wang ZY, Gao Q, Ji Y, Shi YH, Wang XY, Qiu SJ, Huang C, Shen YH, Zhou J, Fan J. Sintilimab plus bevacizumab followed by resection in intermediate-stage hepatocellular carcinoma: a phase Ib clinical trial with biomarker analysis. BMJ Oncol. 2024 Dec 16;3(1):e000578. doi: 10.1136/bmjonc-2024-000578. eCollection 2024.

    PubMed 40046248

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sintilimab and Bevacizumab Biosimilar in people with Hepatocellular Carcinoma, run by Fudan University.

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 11 inclusion and 27 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Huichuan Sun (13701922065, sun.huichuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: Up to 2 years). 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?

On the ClinicalTrials.gov record for NCT04843943, 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 14 Apr 2021.

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