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

• Status: Recruiting
• Trial end date: 2024-02-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborator: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old, ≤ 70 years old, both men and women;

2. Clinical or pathologically confirmed BCLC C-stage hepatocellular carcinoma, no further first-line treatment;

3. At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary tumor burden;

4. Child-Pugh score small or equal to 7 points (Child-Pugh A-B);

5. The liver tumor burden does not exceed 50% of the total liver volume;

6. Patient can swallow tablet normally;

7. ECOG score: 0 to 1 (according to the ECOG score classification);

8. The expected survival is longer than 12 weeks;

Exclusion Criteria:

1. 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.);

2. 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;

3. Severe allergic reactions to other monoclonal antibodies;

4. Known for a history of central nervous system metastasis or hepatic encephalopathy;

5. Having a history of organ transplantation;

6. 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;

7. Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥90 mmHg);

8. 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);

9. 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;