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Hepatocellular CarcinomaPhase 2NCT06538935

SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma

A Phase 2 study testing adbelimumab, SBRT and apatinib in people with Hepatocellular Carcinoma and SBRT, run by Fujian Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
adbelimumab, SBRT and apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Jan 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient volunteered to participate in the study and signed an informed consent form
  • ≥18 years of age，Male or female
  • Subjects are diagnosed with histologically or cytologically confirmed HCC
  • Subjects haven't received any systemic treatment for HCC before admission.
  • Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard
  • ECOG performance status of 0 or 1
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  • Life expectancy ≥ 12 weeks
  • Subjects are diagnosed with resectable stage IB- IIIA HCC cancer.
  • The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)
  • Absolute neutrophil count≥1.5×109 /L
  • Platelets≥75×109/L ;Hemoglobin≥9.0 g/dL; Serum albumin≥3g/dL
  • Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）
  • Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)
  • Serum creatinine ≤1.5×ULN or creatinine clearance > 60 mL/minute (using Cockcroft-Gault formula)

Who cannot join

  • Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
  • Be ready for or previously received organ or allogenic bone marrow transplantation
  • Moderate-to-severe ascites with clinical symptoms
  • History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.
  • Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment.
  • Known genetic or acquired hemorrhage or thrombotic tendency.
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  • Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
  • Cardiac clinical symptom or disease that is not well controlled.
  • Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment ；Subjects have had a hypertensive crisis or hypertensive encephalopathy
  • Patient develops severe vascular disease within 6 months before the start of study treatment.
  • Patients with severe, unhealed or split wounds and active ulcers or untreated fractures.
  • Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment.
  • Factors to affect oral administration (such as patients unable to swallow oral medications, malabsorption syndrome etc. situations evidently affect drug absorption).
  • Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.
  • There is evidence of intragastric gas that cannot be explained by puncture or recent surgery.
  • Previous or current presence of metastasis to central nervous system.
  • Subjects have history of hepatic encephalopathy.
  • The subject has an interstitial lung disease that is symptomatic or may interfere with the discovery or management of suspected drug-related lung toxicity; previous and current subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-associated pneumonia, severe impaired lung function, etc.
  • The patient has any active autoimmune disease or a history of autoimmune disease expected relapse.
  • Severe infection within 4 weeks prior to the start of study treatment.
  • A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease.
  • The patient is pregnant or breastfeeding.
  • Subjects were vaccinated with live attenuated vaccine within 28 days before the first dose or expected to receive this vaccine within 60 days after the last dose or during the study period.
  • Treatment of other investigational product(s) within 28 days prior to the start of study treatment.
  • Other factors deemed unsuitable for participation in this study by the researchers.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jingfeng Liu, DR contact

13905029580

drjingfeng@126.com

Yu Chen, DR contact

13859089836

chenyu1980@fjmu.edu.cn

About this study

Official title: A Phase II, Open-label, Two Arm, Investigator-initiated Trail of Stereotactic Radiotherapy (SBRT) in Combination With an Anti-PD-L1 Inhibitor Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma

This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.

Read the detailed description

This is an Open, Two Arm, Exploratory and Phase II Clinical Trial of SBRT Combined With Adbelimumab (an Anti-PD-L1 Inhibitor) and Apatinib in Patients With Hepatocellular Carcinoma(HCC) as Perioperative and Conversion Treatment. we conduct this study in order to observe and evaluate the efficacy and safety of SBRT Combined With Adbelimumab and Apatinib in treatment of patients with HCC. Primary Efficacy Endpoint: Perioperative cohort-Pathological complete response Rate (pCR); Conversion cohort-Objective Response(ORR) (According to RECIST Version 1.1).Secondary Efficacy Endpoints:Perioperative cohort-Major pathologic response (MPR) ,Event-free survival (EFS) and Overall survival (OS )；Conversion cohort-Radical (R0) resection rate,Disease control rate (DCR),Progression free survival(PFS) and Overall survival (OS ).Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs.

Being tested
adbelimumab, SBRT, apatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • adbelimumabDrug

    adbelimumab：1200mg iv d1 q3w

  • SBRTProcedure or surgery

    SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）; tumor thrombus dose 30Gy /5-6F;

  • apatinibDrug

    apatinib：250mg po, qd

Study groups in NCT06538935
Study groupRoleWhat they receive
Perioperative queueExperimentalSBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）； Adbelimumab: 2-3 cycles of neoadjuvant therapy before surgery, 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Before surgery, the patient's surgical pathology samples still need to be collected. After surgery, patients would receive Adbelimumab and Apatinib as adjuvant therapy .No more than 17 cycles before and after surgery.
Receives: Drug: adbelimumab; Procedure: SBRT; Drug: apatinib
Conversion queueExperimentalSBRT: tumor thrombus dose 30Gy /5-6F; Primary tumor dose is referred to Perioperative queue; Adbelimumab: 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Treatment continues till PD,death,intolerable toxicity,or meet the criteria for Successful transformation(the maximum duration of adbelizumab combined with Apatinib conversion therapy was 1 year).
Receives: Drug: adbelimumab; Procedure: SBRT; Drug: apatinib

What is being measured

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

  1. Pathological complete response Rate (Perioperative cohort)

    No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors

    Measured: 4 months

  2. Objective Response (Conversion cohort)

    It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.

    Measured: 12 months

Secondary outcomes (4)

  1. Event-free survival

    Refers to the time from the start of the group to the occurrence of any event

    Measured: 5 year

  2. Major pathologic response

    It is defined as residual tumors less than 10% after neo-adjuvant therapy

    Measured: 4 months

  3. Overall survival

    It is defined as the time from randomization to death from any cause during the course of the study

    Measured: 5 year

  4. Safety as measured by the rate of AEs

    Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs)

    Measured: 1 month

Timeline

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

  1. First posted6 Aug 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538935
Sponsor's protocol ID
HCC
Status last verified
Jul 2024
First submitted
31 Jul 2024
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing adbelimumab, SBRT and apatinib in people with Hepatocellular Carcinoma and SBRT, run by Fujian Cancer Hospital.

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 14 inclusion and 25 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: opening soon, as of the sponsor's last update on 6 Aug 2024. 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Jingfeng Liu, DR (13905029580, drjingfeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response Rate (Perioperative cohort) (time frame: 4 months). 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 NCT06538935.

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 6 Aug 2024.

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