Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    Shanghai Zhongshan Hospital
Send
Updated on 16 February 2024
See if I qualify
microwave ablation
carcinoma
pd-1 inhibitor
hepatocellular carcinoma
TACE
sintilimab
unresectable hepatocellular carcinoma

Summary

Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.

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.

Details
Condition HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA
Age 18years - 80years
Treatment TACE, Sintilimab, Microwave Ablation
Clinical Study IdentifierNCT04220944
SponsorShanghai Zhongshan Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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

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
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

microwave ablation
carcinoma
pd-1 inhibitor
hepatocellular carcinoma
TACE
sintilimab
unresectable hepatocellular carcinoma

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.