TACE Combined With Camrelizumab and Apatinib in the Treatment of Advanced Liver Cancer

NCT05550025 | Unknown Phase 2

• 1 other identifier: 2020-KY-195
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the effectiveness and safety of TACE（transcatheter arterial chemoembolization） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma. The primary outcome measure is to evaluate the objective response rate (ORR) of the therapy for Hepatocellular Carcinoma. The secondary Outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS) of the therapy for Hepatocellular Carcinoma. Moreover, this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) by RECIST 1.1 and mRECIST

  ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

  From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

Secondary Outcomes (1)

• The median overall survival time (mOS)

  From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)

Study Arms (1)

TACE combined with Apatinib and Camrelizumab

EXPERIMENTAL

TACE（transcatheter arterial chemoembolization） combined with Apatinib and Camrelizumab

Drug: camrelizumab& apatinib

Interventions

camrelizumab& apatinib DRUG

TACE（transcatheter arterial chemoembolization） combined with Apatinib and Camrelizumab Camrelizumab 200mg every 3 weeks. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally after meals, once a day, for continuous medication. The cumulative maximum drug use period is up to 1 years. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear.

TACE combined with Apatinib and Camrelizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, ≤ 70 years old, both men and women;
• Clinical or pathologically confirmed BCLC C-stage hepatocellular carcinoma, no further first-line treatment;
• At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary tumor burden;
• Child-Pugh score small or equal to 7 points (Child-Pugh A-B);
• The liver tumor burden does not exceed 50% of the total liver volume;
• Patient can swallow tablet normally;
• ECOG score: 0 to 1 (according to the ECOG score classification);
• The expected survival is longer than 12 weeks;

You may not qualify if:

• The patient has any active auto-immune disease or a history of auto-immune disease (such as the following, but not limited to: auto-immune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients with vitiligo. For patient with history of asthma, complete remission of asthma in childhood without any intervention after adulthood can be included, while those asthma patients who require bronchodilators for medical intervention cannot be included.);
• The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose \> 10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment;
• Severe allergic reactions to other monoclonal antibodies;
• Known for a history of central nervous system metastasis or hepatic encephalopathy;
• Having a history of organ transplantation;
• Patients with clinically symptomatic ascites who require puncture, drainage, or ascites drainage within 3 months, except for those who have a small amount of ascites but no clinical symptoms;
• Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥90 mmHg);
• Suffering heart diseases with clinical symptoms or those not well controlled, such as: (1) heart failure in NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction occurred within 1 year; (4) clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Tc \> 450ms (male); QTc \> 470ms (female);
• Coagulation dysfunction (INR\>2.0, PT\>16s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin or low molecular heparin;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, 510000, China

RECRUITING

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 Officials

• xu Linfeng

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xu Linfeng

CONTACT

13826263989; xulf1@21cn.com

ni jiayan

CONTACT

13660140273; jiayan0129@126.con

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: Director of Interventional Department

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: September 22, 2022
• Study Start: December 17, 2021
• Primary Completion: November 11, 2023
• Study Completion: February 11, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)