Clinical Trials Logo

Clinical Trial Summary

This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Bevacizumab and Sintilimab (Triplet-combined Therapy) for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification. The primary outcome measure is to evaluate the objective response rate (ORR RECIST 1.1) of Triplet-combined Therapy for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification. The secondary Outcome measures include the objective response rate (ORR mRECIST 1.1), duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) [ Time Frame: 6- and 12-month], overall survival rate (OSR) [ Time Frame: 6- and 12-month], the median progression-free survival time (mPFS) and median overall survival time (mOS) of Triplet-combined Therapy for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification. Moreover, this study aims to assess the safety and tolerability of Triplet-combined Therapy for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification.


Clinical Trial Description

Primary liver cancer is a common malignant tumor of the digestive system in the world. There are about 854,000 new incidences and 810,000 mortality each year. In China, there is a high incidence of liver cancer, with about 466,000 new cases and 422,000 mortality each year. Hepatocellular carcinoma (HCC) accounted for about 90% of primary liver cancer in pathological type. Most patients have reached advanced stage or are unresectable when diagnosed and the natural median survival time is only 3 to 4 months. Then only systemic therapy is recommended for patients in advanced HCC in many global guidelines. Hepatic arterial infusion chemotherapy (HAIC) of mFOLFOX7, anti-angiogenic targeting drugs, and antibody immunotherapy against programmed death molecule-1 (PD-1) immunological checkpoints are effective treatment options for advanced hepatocellular carcinoma. Many clinical studies have shown that the two-two combination of the above three treatment options can improve the anti-tumor overall response rate, the survival rate and even achieve clinical complete remission of patients with unresectable HCC. Shi Ming et al reported HAIC combined with systemic targeted therapy has a better survival outcome compared to systemic targeted therapy monotherapy [OS 13.37 vs 7.13 months, PFS 7.03 vs 2.6 months] in JAMA Oncology. In summary, for patients of unresectable Hepatocellular Carcinoma, HAIC, antiangiogenic targeted therapy, and anti-PD-1 immunotherapy have their important status, and the combination of any two treatments brings about synergy effect. Then, could the combination of the three treatment methods further improve the outcome of unresectable hepatocellular carcinoma? This study was designed to evaluate the efficacy and safety of a combination of hepatic arterial infusion chemotherapy, targeted drugs (Apatinib), and anti-PD-1 immunotherapy (Camrelizumab) to provide a more effective and toxic-tolerable treatment for patients in unresectable A-staged Hepatocellular Carcinoma in BCLC classification. This is a single-arm phase II study, and 30 patiented will be enrolled. The patients will receive Hepatic Arterial Infusion(mFOLFOX7) on the first day, and intravenous infusion of Bevacizumab on the 4th day, and intravenous infusion of Sintilimab on the 25th day. The intervention is repeated every 3 weeks. The primary outcome measure is ORR by RECIST 1.1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05214339
Study type Interventional
Source Sun Yat-sen University
Contact Yang-Kui Gu, Prof.
Phone +862087345272
Email guyk@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date March 16, 2022
Completion date June 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Completed NCT00988741 - Trial of ARQ 197 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy Phase 2
Recruiting NCT03942328 - Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer Phase 1/Phase 2
Completed NCT01900002 - Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery Phase 2
Completed NCT06315101 - Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China
Not yet recruiting NCT04947956 - Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma
Completed NCT01004978 - Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery Phase 3
Active, not recruiting NCT01217034 - Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib Phase 2
Terminated NCT03695250 - BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer Phase 1/Phase 2
Completed NCT02006030 - Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma Phase 2
Active, not recruiting NCT03896646 - Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D) N/A
Recruiting NCT05135364 - HAIC Combined With Camrelizumab and TKI for Unresectable Hepatocellular Carcinoma After TACE Failure Phase 2
Recruiting NCT06117891 - An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery
Recruiting NCT05957640 - Yttrium-90 Carbon Microspheres in Patients With Unresectable Hepatocellular Carcinoma Phase 1
Recruiting NCT04736121 - Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients N/A
Recruiting NCT05168163 - Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer Phase 2
Withdrawn NCT03345225 - A Clinical Study of Precision TACE (P-TACE) With Surefire N/A
Recruiting NCT05667064 - Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
Recruiting NCT05269381 - Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors Phase 1/Phase 2
Withdrawn NCT02989870 - Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma Phase 1