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ACTIVE NOT RECRUITING

NCT03869034

PHASE2

HAIC Combined with PD-1 Inhibitor in Potentially Resectable Locally Advanced HCC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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 patients. Our previous study showed that compared to than conventional transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC) has better objective response, better safety profile, and increased resection rates. The PD-1 inhibitors emerged in recent years have shown good momentum in the treatment of hepatocellular carcinoma. The single-drug treatment on advanced hepatocellular carcinoma has a tumor response rate of 17%, the disease control rate exceeds 60%, and the overall survival time exceeds 12 months. And it has good tolerance and less adverse events. In studies of other cancer, combined with traditional chemotherapy can further improve the efficacy of PD-1 inhibitors. Our study is a prospective phase II clinical study for patients with potentially resectable locally advanced hepatocellular carcinoma (tumor confined to the liver with invasion to branches of the portal vein or hepatic vein). Progressive survival (PFS) is the primary end point of study. The OS and overall survival rate, RFS, ORR, DCR, conversion rate, pathological response, and safety are the secondary endpoints. The efficacy and safety of HAIC combined with PD-1 inhibitor in the treatment of potentially resectable locally advanced hepatocellular carcinoma will be discussed.

Official title: Hepatic Arterial Infusion Chemotherapy Combined with PD-1 Inhibitor in Treating Potentially Resectable Locally Advanced Hepatocellular Carcinoma: a Prospective, Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-03-25

Completion Date

2025-12-31

Last Updated

2024-12-03

Healthy Volunteers

Conditions

Hepatocellular Carcinoma

Interventions

COMBINATION_PRODUCT

HAIC+PD1

Sintilimab ( 200mg Q3W iv D1)+FOLFOX-HAIC（oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3), maximally 8 cycles Multi-disciplinary consultation was organized to decide the chance of surgery and subsequent treatment per 2 treatment cycles. Patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection. After recovery from operation , sintilimab monotherapy was given per three weeks for maximally 16 doses. Patients who were ineligible for resection would continue to receive the combination therapy.

DRUG

HAIC

FOLFOX-HAIC: oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3, for maximally 8 cycles, and the safety parameters are reviewed before the start of each course of HAIC treatment. Patients who achieve partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and are assessed as eligible for R0 resection go on to undergo surgical resection. No other anti-tumor therapies are allowed before PD or postoperative relapse is confirmed.

Inclusion Criteria: 1. Age between 18 years and 70 years. 2. Hepatocellular carcinoma: patients need to be diagnosed as hepatocellular carcinoma (HCC) histologically before treatment. 3. Never received any anti-cancer treatment in the past. 4. 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. 5. No extrahepatic metastases. 6. No contraindications for the treatment of HAIC and PD-1 inhibitors. 7. KPS≥90. 8. Liver function: Child-Pugh class A. 9. The expected survival of the patient is more than 6 months. 10. Adequate hematological and organ function. 11. 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. 12. Agree to accept postoperative follow-up required by the design of this study. 13. 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 Criteria: 1. 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). 2. With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT). 3. Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range. 4. Patients with tumor thrombus reaches or exceeds the portal vein. 5. History of other malignancies. 6. History of allergic reactions to related drugs. 7. History of organ transplantation. 8. Pregnant women, nursing mothers. 9. Patients have other factors that may interfere with patient enrollment and assessment results. 10. Refuse follow-up as required by this study protocol and refuse to sign informed consent.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China