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
NCT ID: NCT05546619
Last Updated: 2022-09-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-01
Study Completion Date
2025-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Hepatocellular Carcinoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treating with a Design Protocol
Group Type
EXPERIMENTAL
HIPEC+tislelizumab + targeted therapy
Intervention Type
DRUG
Patients with open liver lobe/segment resection, tumor excision, lymph node dissection will receive medication.
Interventions
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HIPEC+tislelizumab + targeted therapy
Patients with open liver lobe/segment resection, tumor excision, lymph node dissection will receive medication.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* (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.
(2)18-70 years (3) Liver function: Child-Pugh A、B (4) Patients voluntarily receive treatment with this program.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Sulai Liu
OTHER
Sponsor Role
lead
Responsible Party
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Sulai Liu
Dc.
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
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Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan, China
Site Status
Countries
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China
References
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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.
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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.
Reference Type
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.
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
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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.
Reference Type
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.
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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.
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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.
Reference Type
DERIVED
Other Identifiers
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SLiu
Identifier Type: -
Identifier Source: org_study_id
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