Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients

NCT05213221 | Completed Phase 2

• 1 other identifier: CISLD-12
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, open, single-arm, phase II clinical trial. Eligible HCC patients, after signing informed consent, will receive TACE treatment. Envafolimab combined with Lenvatinib will be started on the day of TACE, and the subsequent TACE will be performed on demand. Patients will receive the treatment continuously until disease progression or intolerance. Tumor imaging evaluation will be performed according to RECIST V1.1 criteria every 6 weeks. Safety will be assessed with CTCAE 5.0. Adverse events throughout and within 30 days of the end of the study will be recorded (severe adverse events or adverse events associated with Envafolimab will be recorded within 90 days after the end of treatment).Treatment will last for 2 years or until disease progression, withdrawal of informed consent, loss of visit, or death.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective reponse rate (ORR)

  The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during study

  Up to 2 years.

Secondary Outcomes (5)

• Disease control rate (DCR)

  Up to 2 years.

• Duration of remission （DoR）

  Up to 2 years.

• Progression-free survival （PFS）

  Up to 2 years.

• Overall survival (OS)

  Up to 2 years.

• Safety of treatment

  Up to 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

Envafolimab, Lenvatinib and TACE

Drug: Envafolimab; Procedure: TACE; Drug: Lenvatinib

Interventions

Envafolimab DRUG

300mg, subcutaneous injection, q3w

Treatment group

TACE PROCEDURE

The first TACE will be started on d1, and the subsequent TACE will be performed on demand.

Treatment group

Lenvatinib DRUG

8mg,QD (body weight \<60kg); 12mg, QD (body weight ≥ 60kg)

Treatment group

Eligibility Criteria

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

You may qualify if:

• Sign a written informed consent form prior to enrollment;
• Age was 18-75 years old;
• Hepatocellular carcinoma (HCC) was confirmed by imaging or histology or cytology;
• Patients with stage C and B unresectable BCLC stage (either with portal cancer emboli including VP1-3, but not enrolled if the main portal cancer embolus completely blocked blood vessels and had no blood flow passage)
• With measurable foci (non-lymph node lesion CT scan long diameter ≥ 10 mm, lymph node lesion CT scan short diameter ≥ 15 mm according to RECIST 1.1 criteria);
• Has never previously received any antitumor system treatment, especially the immunotherapy;
• ECOG score: 0\~1;
• Child-Pugh score ≤ 7;
• Have adequate organ function;
• Estimated survival period of ≥ for 3 months;

You may not qualify if:

• Previously diagnosed by histology/cytology with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
• The patient has suffered from other malignant tumors in the past or at the same time.
• Patients who have received systemic anti-tumor therapy in the past;
• For HCC lesions ≥10cm in any dimension, there are more than 10 lesions evaluated by imaging or HCC lesions account for ≥50% of the liver volume;
• Is a current candidate for liver transplantation or has experienced liver transplantation;
• There is a risk of bleeding, or coagulation dysfunction, or is undergoing thrombolytic therapy; or has had bleeding from esophageal or gastric varices in the past 6 months;
• Portal vein tumor thrombus Vp4.
• The patient is known to have been allergic to macromolecular protein preparations or applied drug components;
• The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis Patients with abnormal thyroid function (hyperthyroidism/decreased thyroid function), and the use of drugs cannot maintain thyroid function in the normal range, or previous thyroid surgery, patients who need long-term thyroxine and other drug replacement therapy after surgery; the patient has Vitiligo or asthma has been completely relieved in childhood, and those without any intervention after adulthood can be included; asthma whose patients require medical intervention with bronchodilators cannot be included)
• The patient is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose\>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use;
• The patient is still using traditional Chinese medicine or other immunomodulators within 2 weeks before enrollment;
• Ascites or pleural effusion with clinical symptoms cannot be controlled with drugs and requires therapeutic puncture or drainage;
• There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure above NYHA level 2 (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Supraventricular with clinical significance Or patients with ventricular arrhythmia in need of treatment or intervention;
• Severe infections that are active or poorly clinically controlled. Severe infections within 4 weeks before the first administration, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia, or fever of unexplained occurrence\> 38.5 degrees during the screening period and before the first administration (by research According to the judge, the patient can be included in the group for fever caused by the tumor);
• Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; patients with known syphilis infection requiring treatment; active tuberculosis ( Active tuberculosis, TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before the first administration.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Chen Y, Zhang J, Hu W, Li X, Sun K, Shen Y, Zhang M, Wu J, Gao S, Yu J, Que R, Zhang Y, Yang F, Xia W, Zhang A, Tang X, Bai X, Liang T. Envafolimab plus lenvatinib and transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: a prospective, single-arm, phase II study. Signal Transduct Target Ther. 2024 Oct 9;9(1):280. doi: 10.1038/s41392-024-01991-1.

  PMID: 39384742 DERIVED

MeSH Terms

Interventions

envafolimab; lenvatinib

Study Officials

• Tingbo Liang, PhD

  Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 28, 2022
• Study Start: March 14, 2022
• Primary Completion: September 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)