Active, not recruitingNCT04220944Updated Aug 1, 2024

Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

A Phase 1 interventional study of Sintilimab and Microwave Ablation in Hepatic Carcinoma, sponsored by Shanghai Zhongshan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Shanghai Zhongshan Hospital · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as active, not recruiting.

Phase: Phase 1
Study type: Interventional
Enrollment: 45
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study summary

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 studied

Hepatic Carcinoma

Browse trials for

Carcinoma, Hepatocellular 3,182

Keywords

HCC
Microwave ablation
TACE
Immunotherapy

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 953 are open to participants now.

This study's planned enrollment of 45 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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:
1. Known hepatofugal blood flow;
2. Total thrombosis of main portal vein.
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;
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 45 participants (estimated)

Study arms

Experimental
Locoregional therapies combined with Anti-PD-1 antibody
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.
Drug: Sintilimab · Procedure: Microwave Ablation · Procedure: TACE

Interventions

DrugSintilimab
Sintilimab (200mg) was administered intravenously over 30-60 min every 3 weeks.
Also known as: Sintilimab injection, 308004
ProcedureMicrowave Ablation
The ablation area should covered at least two thirds the size of the nodules.
ProcedureTACE
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.

What researchers measure

Primary outcomes

Progression Free Survival (PFS)
Progression according to mRECIST for HCC.
Time frame: Observation period max 18 months

Secondary outcomes

Objective Response Rate (ORR)
Objective Response Rate according to mRECIST for HCC
Time frame: 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.
Time frame: max 18 months
Overall survival (OS)
Overall survival is defined as the time from first locoregional therapy until death
Time frame: 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
Time frame: max 18 months

Study locations

1 site

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
Shanghai, Shanghai 200032, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04220944
Lead sponsor: Shanghai Zhongshan Hospital
Collaborators: Innovent Biologics (Suzhou) Co. Ltd.
Responsible party: Sponsor
First posted: Jan 7, 2020
Start date: Jan 1, 2020
Primary completion: Oct 30, 2024 (estimated)
Completion: Dec 30, 2024 (estimated)
Last update: Aug 1, 2024

Study contacts

zhiping Yan, MD

study director · Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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