Research on Effectiveness and Safety of the Treatment, Hyperthermic Intraperitoneal Chemotherapy Combined With Tislelizumab and Targeted Therapy, That is Used for High-risk Hepatocellular Carcinoma After R0 Resection

NCT05546619 | Unknown

• 1 other identifier: SLiu
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

There are limited treatment options for HCC with high recurrence risk, and there is no consistent plan for adjuvant therapy after surgery. Hence an unmet clinical need. Based on previous studies on unresectable HCC patients combined with targeted and immunotherapy, it has been found that the effect is significant, but the effect of combined with HIPEC is not clear, and no similar studies have been reported. Therefore, this project intends to carry out a single-arm clinical study on the efficacy and safety of HIPEC + tislelizumab combined with targeted therapy for high recurrence risk HCC. And observe the clinical benefits, to provide new ideas and evidence-based basis for the treatment of HCC with high recurrence risk.

Conditions

Hepatocellular Carcinoma

Keywords

High-risk hepatocellular carcinoma; Adjuvant therapy; HIPEC; Tislelizumab

Outcome Measures

Primary Outcomes (1)

• RFS

  Relapse free survival

  1 year

Secondary Outcomes (1)

• OS

  10 years

Study Arms (1)

Treating with a Design Protocol

EXPERIMENTAL

Drug: HIPEC+tislelizumab + targeted therapy

Interventions

HIPEC+tislelizumab + targeted therapy DRUG

Patients with open liver lobe/segment resection, tumor excision, lymph node dissection will receive medication.

Treating with a Design Protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) In line with the diagnostic criteria of Western medicine, the pathological section was diagnosed as HCC; imaging and intraoperative exploration of HCC patients with high risk of recurrence: multiple tumors or satellite lesions, tumor diameter\>5cm, HCC rupture and bleeding, combined with vascular invasion, and serum AFP\>32ng/ml.
• (2)18-70 years (3) Liver function: Child-Pugh A、B (4) Patients voluntarily receive treatment with this program.

Sponsors & Collaborators

• Sulai Liu: lead

Study Sites (1)

Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)

Changsha, Hunan, 410000, China

Location

Related Publications (32)

• Gentile D, Donadon M, Lleo A, Aghemo A, Roncalli M, di Tommaso L, Torzilli G. Surgical Treatment of Hepatocholangiocarcinoma: A Systematic Review. Liver Cancer. 2020 Jan;9(1):15-27. doi: 10.1159/000503719. Epub 2019 Nov 1.

  PMID: 32071906 RESULT

• Foerster F, Gairing SJ, Muller L, Galle PR. NAFLD-driven HCC: Safety and efficacy of current and emerging treatment options. J Hepatol. 2022 Feb;76(2):446-457. doi: 10.1016/j.jhep.2021.09.007. Epub 2021 Sep 20.

  PMID: 34555422 RESULT

• Satriano L, Lewinska M, Rodrigues PM, Banales JM, Andersen JB. Metabolic rearrangements in primary liver cancers: cause and consequences. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):748-766. doi: 10.1038/s41575-019-0217-8. Epub 2019 Oct 30.

  PMID: 31666728 RESULT

• Ding X, He M, Chan AWH, Song QX, Sze SC, Chen H, Man MKH, Man K, Chan SL, Lai PBS, Wang X, Wong N. Genomic and Epigenomic Features of Primary and Recurrent Hepatocellular Carcinomas. Gastroenterology. 2020 May 16:S0016-5085(20)30659-4. doi: 10.1053/j.gastro.2019.09.056. Online ahead of print.

  PMID: 32428506 RESULT

• Li X, Ramadori P, Pfister D, Seehawer M, Zender L, Heikenwalder M. The immunological and metabolic landscape in primary and metastatic liver cancer. Nat Rev Cancer. 2021 Sep;21(9):541-557. doi: 10.1038/s41568-021-00383-9. Epub 2021 Jul 29.

  PMID: 34326518 RESULT

• Wang H, Lu Z, Zhao X. Tumorigenesis, diagnosis, and therapeutic potential of exosomes in liver cancer. J Hematol Oncol. 2019 Dec 9;12(1):133. doi: 10.1186/s13045-019-0806-6.

  PMID: 31815633 RESULT

• Sharma SA, Kowgier M, Hansen BE, Brouwer WP, Maan R, Wong D, Shah H, Khalili K, Yim C, Heathcote EJ, Janssen HLA, Sherman M, Hirschfield GM, Feld JJ. Toronto HCC risk index: A validated scoring system to predict 10-year risk of HCC in patients with cirrhosis. J Hepatol. 2017 Aug 24:S0168-8278(17)32248-1. doi: 10.1016/j.jhep.2017.07.033. Online ahead of print.

  PMID: 28844936 RESULT

• Bhatt A, de Hingh I, Van Der Speeten K, Hubner M, Deraco M, Bakrin N, Villeneuve L, Kusamura S, Glehen O. HIPEC Methodology and Regimens: The Need for an Expert Consensus. Ann Surg Oncol. 2021 Dec;28(13):9098-9113. doi: 10.1245/s10434-021-10193-w. Epub 2021 Jun 17.

  PMID: 34142293 RESULT

• Pameijer CR. HIPEC Trials and the US: A Review and Call to Action. Ann Surg Oncol. 2022 Feb;29(2):866-872. doi: 10.1245/s10434-021-10769-6. Epub 2021 Oct 1. No abstract available.

  PMID: 34599434 RESULT

• Blumenthaler AN, Allen CJ, Ikoma N, Blum M, Das P, Minsky BD, Mansfield PF, Ajani JA, Badgwell BD. Laparoscopic HIPEC for Low-Volume Peritoneal Metastasis in Gastric and Gastroesophageal Adenocarcinoma. Ann Surg Oncol. 2020 Dec;27(13):5047-5056. doi: 10.1245/s10434-020-08968-8. Epub 2020 Jul 31.

  PMID: 32737700 RESULT

• Klempner SJ, Ryan DP. HIPEC for colorectal peritoneal metastases. Lancet Oncol. 2021 Feb;22(2):162-164. doi: 10.1016/S1470-2045(20)30693-8. Epub 2021 Jan 18. No abstract available.

  PMID: 33476594 RESULT

• van Stein RM, Aalbers AGJ, Sonke GS, van Driel WJ. Hyperthermic Intraperitoneal Chemotherapy for Ovarian and Colorectal Cancer: A Review. JAMA Oncol. 2021 Aug 1;7(8):1231-1238. doi: 10.1001/jamaoncol.2021.0580.

  PMID: 33956063 RESULT

• Strijker D, Meijerink WJHJ, Bremers AJA, de Reuver P, van Laarhoven CJHM, van den Heuvel B. Prehabilitation to improve postoperative outcomes in patients with peritoneal carcinomatosis undergoing hyperthermic intraperitoneal chemotherapy (HIPEC): A scoping review. Eur J Surg Oncol. 2022 Mar;48(3):657-665. doi: 10.1016/j.ejso.2021.10.006. Epub 2021 Oct 20.

  PMID: 34702591 RESULT

• Gulmez S, Polat E, Duman U, Senger AS, Uzun O, Ozduman O, Oz A, Subasi IE, Duman M. Hepatic bridge and round ligament of the liver during cytoreductive surgery: a retrospective cohort. Langenbecks Arch Surg. 2022 May;407(3):1201-1207. doi: 10.1007/s00423-021-02386-4. Epub 2021 Nov 29.

  PMID: 34845541 RESULT

• Liu S, Zhong Z, Yi W, Yu Z, Zhang Z, Xia G, Jiang B, Song Y, Peng C. Effect of Hyperthermic Intraperitoneal Perfusion Chemotherapy Combined with Radical Surgery and Capecitabine on Stage III Gallbladder Cancer. Can J Gastroenterol Hepatol. 2021 Oct 8;2021:4006786. doi: 10.1155/2021/4006786. eCollection 2021.

  PMID: 34660468 RESULT

• Riley RS, June CH, Langer R, Mitchell MJ. Delivery technologies for cancer immunotherapy. Nat Rev Drug Discov. 2019 Mar;18(3):175-196. doi: 10.1038/s41573-018-0006-z.

  PMID: 30622344 RESULT

• O'Donnell JS, Teng MWL, Smyth MJ. Cancer immunoediting and resistance to T cell-based immunotherapy. Nat Rev Clin Oncol. 2019 Mar;16(3):151-167. doi: 10.1038/s41571-018-0142-8.

  PMID: 30523282 RESULT

• Marabelle A, Tselikas L, de Baere T, Houot R. Intratumoral immunotherapy: using the tumor as the remedy. Ann Oncol. 2017 Dec 1;28(suppl_12):xii33-xii43. doi: 10.1093/annonc/mdx683.

  PMID: 29253115 RESULT

• Ziogas IA, Evangeliou AP, Giannis D, Hayat MH, Mylonas KS, Tohme S, Geller DA, Elias N, Goyal L, Tsoulfas G. The Role of Immunotherapy in Hepatocellular Carcinoma: A Systematic Review and Pooled Analysis of 2,402 Patients. Oncologist. 2021 Jun;26(6):e1036-e1049. doi: 10.1002/onco.13638. Epub 2021 Jan 2.

  PMID: 33314549 RESULT

• Osarogiagbon RU. Tislelizumab-A Promising New Option for Enhancing Chemotherapy Benefit in Treatment for Advanced Squamous Cell Lung Cancer. JAMA Oncol. 2021 May 1;7(5):717-719. doi: 10.1001/jamaoncol.2021.0262. No abstract available.

  PMID: 33792622 RESULT

• Lee A, Keam SJ. Tislelizumab: First Approval. Drugs. 2020 Apr;80(6):617-624. doi: 10.1007/s40265-020-01286-z.

  PMID: 32185681 RESULT

• Yi M, Zheng X, Niu M, Zhu S, Ge H, Wu K. Combination strategies with PD-1/PD-L1 blockade: current advances and future directions. Mol Cancer. 2022 Jan 21;21(1):28. doi: 10.1186/s12943-021-01489-2.

  PMID: 35062949 RESULT

• Shen L, Guo J, Zhang Q, Pan H, Yuan Y, Bai Y, Liu T, Zhou Q, Zhao J, Shu Y, Huang X, Wang S, Wang J, Zhou A, Ye D, Sun T, Gao Y, Yang S, Wang Z, Li J, Wu YL. Tislelizumab in Chinese patients with advanced solid tumors: an open-label, non-comparative, phase 1/2 study. J Immunother Cancer. 2020 Jun;8(1):e000437. doi: 10.1136/jitc-2019-000437.

  PMID: 32561638 RESULT

• Kissel M, Berndt S, Fiebig L, Kling S, Ji Q, Gu Q, Lang T, Hafner FT, Teufel M, Zopf D. Antitumor effects of regorafenib and sorafenib in preclinical models of hepatocellular carcinoma. Oncotarget. 2017 Nov 6;8(63):107096-107108. doi: 10.18632/oncotarget.22334. eCollection 2017 Dec 5.

  PMID: 29291014 RESULT

• Saraswati S, Alhaider A, Abdelgadir AM, Tanwer P, Korashy HM. Phloretin attenuates STAT-3 activity and overcomes sorafenib resistance targeting SHP-1-mediated inhibition of STAT3 and Akt/VEGFR2 pathway in hepatocellular carcinoma. Cell Commun Signal. 2019 Oct 16;17(1):127. doi: 10.1186/s12964-019-0430-7.

  PMID: 31619257 RESULT

• Matsuki M, Hoshi T, Yamamoto Y, Ikemori-Kawada M, Minoshima Y, Funahashi Y, Matsui J. Lenvatinib inhibits angiogenesis and tumor fibroblast growth factor signaling pathways in human hepatocellular carcinoma models. Cancer Med. 2018 Jun;7(6):2641-2653. doi: 10.1002/cam4.1517. Epub 2018 May 7.

  PMID: 29733511 RESULT

• Ogasawara S, Mihara Y, Kondo R, Kusano H, Akiba J, Yano H. Antiproliferative Effect of Lenvatinib on Human Liver Cancer Cell Lines In Vitro and In Vivo. Anticancer Res. 2019 Nov;39(11):5973-5982. doi: 10.21873/anticanres.13802.

  PMID: 31704822 RESULT

• Ikeda K, Kudo M, Kawazoe S, Osaki Y, Ikeda M, Okusaka T, Tamai T, Suzuki T, Hisai T, Hayato S, Okita K, Kumada H. Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma. J Gastroenterol. 2017 Apr;52(4):512-519. doi: 10.1007/s00535-016-1263-4. Epub 2016 Oct 4.

  PMID: 27704266 RESULT

• Alsina A, Kudo M, Vogel A, Cheng AL, Tak WY, Ryoo BY, Evans TRJ, Lopez Lopez C, Daniele B, Misir S, Ren M, Izumi N, Qin S, Finn RS. Effects of Subsequent Systemic Anticancer Medication Following First-Line Lenvatinib: A Post Hoc Responder Analysis from the Phase 3 REFLECT Study in Unresectable Hepatocellular Carcinoma. Liver Cancer. 2020 Jan;9(1):93-104. doi: 10.1159/000504624. Epub 2019 Dec 16.

  PMID: 32071913 RESULT

• Zhang BH, Cai YS, Jiang L, Yang JY. Donafenib as a first-line monotherapy for advanced hepatocellular carcinoma. Hepatobiliary Surg Nutr. 2021 Oct;10(5):737-740. doi: 10.21037/hbsn-21-304. No abstract available.

  PMID: 34760990 RESULT

• Qin S, Bi F, Gu S, Bai Y, Chen Z, Wang Z, Ying J, Lu Y, Meng Z, Pan H, Yang P, Zhang H, Chen X, Xu A, Cui C, Zhu B, Wu J, Xin X, Wang J, Shan J, Chen J, Zheng Z, Xu L, Wen X, You Z, Ren Z, Liu X, Qiu M, Wu L, Chen F. Donafenib Versus Sorafenib in First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma: A Randomized, Open-Label, Parallel-Controlled Phase II-III Trial. J Clin Oncol. 2021 Sep 20;39(27):3002-3011. doi: 10.1200/JCO.21.00163. Epub 2021 Jun 29.

  PMID: 34185551 RESULT

• Zhou J, Tan Z, Sun B, Leng Y, Liu S. Application of indocyanine green fluorescence imaging in hepatobiliary surgery. Int J Surg. 2024 Dec 1;110(12):7948-7961. doi: 10.1097/JS9.0000000000001802.

  PMID: 38884267 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dc.

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)