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AzTrials

Hepatocellular CarcinomaNCT05546619

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

A study testing HIPEC+tislelizumab + targeted therapy in people with Hepatocellular Carcinoma, run by Sulai Liu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
HIPEC+tislelizumab + targeted therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Aug 2022to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (1) Patients did not meet the inclusion criteria. (2) Use of other antineoplastic drugs during the follow-up period (3) Severe heart and kidney damage. (4) Failure to follow the prescription for medication, and unable to judge the efficacy or incomplete information (5) Not suitable for targeted therapy and anti-PD1 immunotherapy.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Changsha, Hunan, 410000

Other trials in China

About this study

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.

Being tested
HIPEC+tislelizumab + targeted therapy
Keywords
High-risk hepatocellular carcinoma; Adjuvant therapy; HIPEC; Tislelizumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIPEC+tislelizumab + targeted therapyDrug

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

Study groups in NCT05546619
Study groupRoleWhat they receive
Treating with a Design ProtocolExperimentalNot described
Receives: Drug: HIPEC+tislelizumab + targeted therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RFS

    Relapse free survival

    Measured: 1 year

Secondary outcomes (1)

  1. OS

    Overall survival

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546619
Sponsor's protocol ID
SLiu
Status last verified
Sep 2022
First submitted
15 Sep 2022
Last updated
21 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32071906

  • 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.

    PubMed 34555422

  • 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.

    PubMed 31666728

  • 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.

    PubMed 32428506

  • 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.

    PubMed 34326518

  • 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.

    PubMed 31815633

  • 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.

    PubMed 28844936

  • 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.

    PubMed 34142293

  • 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.

    PubMed 34599434

  • 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.

    PubMed 32737700

  • 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.

    PubMed 33476594

  • 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.

    PubMed 33956063

  • 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.

    PubMed 34702591

  • 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.

    PubMed 34845541

  • 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.

    PubMed 34660468

Questions about this trial

What is this clinical trial studying?

A study testing HIPEC+tislelizumab + targeted therapy in people with Hepatocellular Carcinoma, run by Sulai Liu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RFS (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05546619, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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