PD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC

NCT04974281 | Unknown Early Phase 1

• 1 other identifier: HUASHAN007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.

Conditions

Hepatocellular Carcinoma

Keywords

Lenvatinib; PD-1; TACE; Downstaging

Outcome Measures

Primary Outcomes (1)

• Resection rate

  Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.

  6 months after downstaging treatment

Secondary Outcomes (4)

• Adverse events (safety)

  6 months

• Overall survival (OS)

  2 years

• Objective response rate (ORR)

  6 months

• Progression free survival (PFS)

  6 months

Study Arms (1)

PD-1+TACE+Len

OTHER

PD-1 Antibody and Lenvatinib Plus TACE

Combination Product: PD-1 and Lenvatinib Plus TACE

Interventions

PD-1 and Lenvatinib Plus TACE COMBINATION_PRODUCT

PD-1 Antibody and Lenvatinib Plus Transarterial chemoembolization(TACE )： Patients were recommended to receive TACE once every 6 weeks. Patients were recommended to begin oral administration of Lenvatinib 3 days after the first TACE treatment, and meanwhile to start intravenous drip of PD-1 antibody 3 days after the first TACE treatment, once every 3 weeks.

PD-1+TACE+Len

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old and ≤75 years old;
• Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
• No history of severe arrhythmia or heart failure;
• No history of severe ventilation dysfunction or severe pulmonary infection;
• No acute or chronic renal failure, the creatinine clearance rate was \>40 mL/min;
• Liver function Child A;
• Blood routine: absolute neutrophils count ≥1.5×10\^9/L, Hb≥8.5g/L, PLT≥75×10\^9/L;
• Coagulation function: INR≤2.3;
• ECOG score \<2;
• No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
• Expected survival ≥12 weeks;
• At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
• Understand and sign the informed consent.

You may not qualify if:

• Pregnant or lactating women;
• Patients with other malignant tumors;
• patients with complicated mental illness;
• patients who have participated in other clinical trials in the last three months;
• known or suspected allergy to any drug related to the study;
• Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
• Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group.
• Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
• Patients with uncontrolled hepatitis B/C infection

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huashan hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (5)

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Lencioni R, de Baere T, Soulen MC, Rilling WS, Geschwind JF. Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data. Hepatology. 2016 Jul;64(1):106-16. doi: 10.1002/hep.28453. Epub 2016 Mar 7.

  PMID: 26765068 BACKGROUND

• Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

  PMID: 29433850 BACKGROUND

• Kato Y, Tabata K, Kimura T, Yachie-Kinoshita A, Ozawa Y, Yamada K, Ito J, Tachino S, Hori Y, Matsuki M, Matsuoka Y, Ghosh S, Kitano H, Nomoto K, Matsui J, Funahashi Y. Lenvatinib plus anti-PD-1 antibody combination treatment activates CD8+ T cells through reduction of tumor-associated macrophage and activation of the interferon pathway. PLoS One. 2019 Feb 27;14(2):e0212513. doi: 10.1371/journal.pone.0212513. eCollection 2019.

  PMID: 30811474 BACKGROUND

• Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Yasui K, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Yokosuka O, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y; TACTICS study group. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020 Aug;69(8):1492-1501. doi: 10.1136/gutjnl-2019-318934. Epub 2019 Dec 4.

  PMID: 31801872 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

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 Officials

• Lunxiu Qin, M.D

  Department of Surgery, Huashan Hospital, Fudan University

  STUDY DIRECTOR

Central Study Contacts

Lunxiu Qin, M.D

CONTACT

+862152887172; qinlx99@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 23, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CN (1)