Status:
ACTIVE_NOT_RECRUITING
HAIC Combined with PD-1 Inhibitor in Potentially Resectable Locally Advanced HCC
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Innovent Biologics, Inc.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Hepatocellular carcinoma patients are mostly diagnosed at locally advanced stage. Nowadays, hepatic artery interventional therapy and/or systemic therapy are the main treatments options for these pati...
Detailed Description
Sintilimab (IBI308) is a recombinant human IgG4 PD-1 monoclonal antibody. It has been proved in many preclinical and in vitro trials that the effect of blocking PD-1 pathway with Sintilimab on. The re...
Eligibility Criteria
Inclusion
- Age between 18 years and 70 years.
- Hepatocellular carcinoma: patients need to be diagnosed as hepatocellular carcinoma (HCC) histologically before treatment.
- Never received any anti-cancer treatment in the past.
- potentially resectable Locally advanced HCC: with at least one measurable lesion (RECIST 1.1), and tumor(s) confined to the left or right hemi-liver, with macroscopic invasion to branch of the portal vein and/or hepatic vein.
- No extrahepatic metastases.
- No contraindications for the treatment of HAIC and PD-1 inhibitors.
- KPS≥90.
- Liver function: Child-Pugh class A.
- The expected survival of the patient is more than 6 months.
- Adequate hematological and organ function.
- The following conditions are met:
- Platelet≥75×10\^9/L; White blood cell≥3.0×10\^9/L; Hemoglobin≥90 g/L; Serum creatinine≤1.5 × upper limit of normal (ULN); PT≤3 second extension; total bilirubin ≤1.5 x ULN； AST and ALT ≤2.5 x ULN.
- Agree to accept postoperative follow-up required by the design of this study.
- Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study.
Exclusion
- In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (\> CTCAE Version 4.03 adverse events of grade 2).
- With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT).
- Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
- Patients with tumor thrombus reaches or exceeds the portal vein.
- History of other malignancies.
- History of allergic reactions to related drugs.
- History of organ transplantation.
- Pregnant women, nursing mothers.
- Patients have other factors that may interfere with patient enrollment and assessment results.
- Refuse follow-up as required by this study protocol and refuse to sign informed consent.
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03869034
Start Date
March 25 2019
End Date
December 31 2025
Last Update
December 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060