Hepatic CarcinomaPhase 1NCT04220944
Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.
A Phase 1 study testing Sintilimab, Microwave Ablation and TACE in people with Hepatic Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Carcinoma
- What is being tested?
- Sintilimab, Microwave Ablation and TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Dec 2024
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 80 years old and life expectancy of at least 12 weeks.;
- Clinically or histologically diagnosed as HCC and the diameter of target tumor lesion ≥ 5 cm;
- Child-pugh classification A or B (score < 7);
- BCLC Staging as B or C;
- ECOG 0-1;
- Patients voluntarily entered the study and signed informed consent form (ICF).
Who cannot join
- History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy;
- The surgeon assessed that the tumor lesion was not unsuitable for microwave ablation;
- Any contraindications for hepatic embolization procedures:
- Known hepatofugal blood flow;
- Total thrombosis of main portal vein.
- The tumor thrombus of main portal vein, IVC or right atrium;
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- Tumor burden ≥ 70% of liver volume; and no measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI;
- Subjects with chronic HBV infection have HBV DNA viral load > 100 IU/mL at screening, and have not received antiviral therapy prior to initiation of study therapy; In addition, coinfection of HBV and HCV;
- The alcoholic or pregnant women;
- Patients with second primary cancer or history of other cancer within 3 years;
- Diagnosis of active autoimmune disease, immunodeficiency, or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Sintilimab-monotherapy treatment;
- Blood count, liver function: Haemoglobin < 9.0 g/dL, white cell count < 1.0 x10^9/L; Total bilirubin > 3 mg/dL; Aspartate Aminotransferase (SGOT) or Alanine aminotransferase (SGPT) > 5 x upper normal limit (ULN), Albumin < 2.8g/dL; International normalized ratio (INR) >2.3;
- Renal function dysfunction: Serum Creatinine >2 mg/dL or creatinine clearance (CrCl) < 30 mL/min (if using the Cockcroft-Gault formula ); and severe heart, lung, brain or other organ disease;
- Non-compliance with TACE or ablation procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Microwave Ablation Combined With Simultaneous TACE Plus Sintilimab for Unresectable HCC.
Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.
Read the detailed description
Hepatocellular carcinoma is the most frequent primary and ranked as the sixth most common neoplasm and the third leading cause of cancer death.
Percutaneous ablation and TACE are the effective locoregional treatments for the patient with HCC. Moreover, some studies suggested that TACE combined with ablation could further improve the survival rate and reduce the post-operation complication.
Although PD-1 inhibitor was approved by FDA for HCC, the latest RCT indicated that no significant difference was found in the ORR and PFS between the groups of PD-1 inhibitor and Sorafenib.
Therefore, this study aims to assess the efficacy and safety of microwave ablation combined with simultaneous TACE plus PD-1 inhibitor for the non-resectable HCC.
- Conditions
- Hepatic Carcinoma
- Being tested
- Sintilimab, Microwave Ablation, TACE
- Keywords
- HCC, Microwave ablation, TACE, Immunotherapy
- 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
Also called Sintilimab injection, 308004
Sintilimab (200mg) was administered intravenously over 30-60 min every 3 weeks.
Microwave AblationProcedure or surgery
The ablation area should covered at least two thirds the size of the nodules.
TACEProcedure or surgery
Patient was treated with epirubicin lipiodol emulsion(Epirubicin 40mg, Lipiodol 10ml).Embolic materials such as gelfoam or microsphere was aslo administered until complete stasis in segmental or subsegmental arterial branches.
| Study group | Role | What they receive |
|---|---|---|
| Locoregional therapies combined with Anti-PD-1 antibody | Experimental | Percutaneous microwave ablation combined with simultaneous TACE was performed. Sintilimab will be initiated on day 3-7 after the first locoregional therapies. Sintilimab will be administered every three weeks (200mg fixed dose IV) until disease progression for up to one year.The second locoregional procedure will be repeated according to the enhanced CT images. Receives: Drug: Sintilimab; Procedure: Microwave Ablation; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression according to mRECIST for HCC.
Measured: Observation period max 18 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Objective Response Rate according to mRECIST for HCC
Measured: max 18 months
Time to Progression (TTP)
It is defined as the time from first locoregional therapy to the date of the first documented tumor progression according to the definition above.
Measured: max 18 months
Overall survival (OS)
Overall survival is defined as the time from first locoregional therapy until death
Measured: max 18 months
Incidence of Treatment Emergent Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)
Data will be obtained on vital signs, clinical parameters and feasibility of the regimen
Measured: max 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Jan 2020
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- zhiping Yan, MD, Study director, Department of Interventional Radiology, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220944
- Sponsor's protocol ID
- ZS-IR-2019B
- Status last verified
- Jul 2024
- First submitted
- 29 Dec 2019
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation Combined With Simultaneous TACE Plus Sintilimab for Unresectable HCC.
- ClinicalTrials.gov ID
- NCT04220944
- Acronym / sponsor ID
- ZS-IR-2019B
- Conditions
- Hepatic Carcinoma
- Keywords
- HCC, Microwave ablation, TACE, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Jan 2020 (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.
Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.
Detailed description
Hepatocellular carcinoma is the most frequent primary and ranked as the sixth most common neoplasm and the third leading cause of cancer death.
Percutaneous ablation and TACE are the effective locoregional treatments for the patient with HCC. Moreover, some studies suggested that TACE combined with ablation could further improve the survival rate and reduce the post-operation complication.
Although PD-1 inhibitor was approved by FDA for HCC, the latest RCT indicated that no significant difference was found in the ORR and PFS between the groups of PD-1 inhibitor and Sorafenib.
Therefore, this study aims to assess the efficacy and safety of microwave ablation combined with simultaneous TACE plus PD-1 inhibitor for the non-resectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locoregional therapies combined with Anti-PD-1 antibody | Experimental | Drug: Sintilimab, Procedure: Microwave Ablation, Procedure: TACEPercutaneous microwave ablation combined with simultaneous TACE was performed. Sintilimab will be initiated on day 3-7 after the first locoregional therapies. Sintilimab will be administered every three weeks (200mg fixed dose IV) until disease progression for up to one year.The second locoregional procedure will be repeated according to the enhanced CT images. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 - 80 years old and life expectancy of at least 12 weeks.;
- Clinically or histologically diagnosed as HCC and the diameter of target tumor lesion ≥ 5 cm;
- Child-pugh classification A or B (score < 7);
- BCLC Staging as B or C;
- ECOG 0-1;
Key exclusion criteria (14 listed)
- History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy;
- The surgeon assessed that the tumor lesion was not unsuitable for microwave ablation;
- Any contraindications for hepatic embolization procedures:
- The tumor thrombus of main portal vein, IVC or right atrium;
- Tumor burden ≥ 70% of liver volume; and no measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI;
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 |
|---|---|---|
| SintilimabAlso: Sintilimab injection, 308004Sintilimab (200mg) was administered intravenously over 30-60 min every 3 weeks. | Drug | Locoregional therapies combined with Anti-PD-1 antibody |
| Microwave AblationThe ablation area should covered at least two thirds the size of the nodules. | Procedure or surgery | Locoregional therapies combined with Anti-PD-1 antibody |
| TACEPatient was treated with epirubicin lipiodol emulsion(Epirubicin 40mg, Lipiodol 10ml).Embolic materials such as gelfoam or microsphere was aslo administered until complete stasis in segmental or subsegmental arterial branches. | Procedure or surgery | Locoregional therapies combined with Anti-PD-1 antibody |
Primary outcome
Progression Free Survival (PFS)
Time frame: Observation period max 18 months
Progression according to mRECIST for HCC.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: max 18 months
Time to Progression (TTP)
Time frame: max 18 months
Overall survival (OS)
Time frame: max 18 months
Incidence of Treatment Emergent Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)
Time frame: max 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
zhiping Yan, MD study director
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sintilimab, Microwave Ablation and TACE in people with Hepatic Carcinoma, run by Shanghai Zhongshan 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 6 inclusion and 14 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 1 Aug 2024. 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 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.
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?
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?
Progression Free Survival (PFS) (time frame: Observation period max 18 months). 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 1 Aug 2024.