HAIC Combined With Camrelizumab and TKI for Unresectable Hepatocellular Carcinoma After TACE Failure

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

Hepatic Artery Infusion Chemotherapy (HAIC) Combined With Camrelizumab and Tyrosine Kinase Inhibitor for Unresectable Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization (TACE) Failure: a Single-arm and Open-label Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135364
• Other study ID #: NCC3153
• Status: Recruiting
• Phase: Phase 2
• Start date: November 5, 2021
• Est. completion date: December 5, 2024

Study information

• Verified date: November 2021
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: yue Han, phD
• Phone: 13511021629
• Email: doctorhan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy and safety of HAIC combined with tyrosine kinase inhibitor and immunotherapy have been proved by the clinical research. In this single-arm, open-label, prospective study, for those patients with unresectable primary HCC, in the case of failure of TACE treatment, the combination of HAIC, TKI and immunotherapy is expected to bring new breakthroughs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 5, 2024
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Paticipants voluntarily joined the study and signed the informed consent form

2. Above 18 years old, both male and female

3. Clinical diagnosis or histopathologically confirmed advanced hepatocellular carcinoma (unresectable)

4. Child-Pugh score = 7

5. BCLC B and C

6. TACE failure: ? Even if chemotherapeutic drugs are changed or the blood supply artery is reassessed, CT/MRI examinations after 2 consecutive TACE treatments 1-3 months show that the target lesions in the liver are compared with the previous TACE count. There are still more than 50% remaining or new lesions; ? extrahepatic metastasis or vascular invasion; ? postoperative tumor indicators continue to rise (even if there is a short-term decline)

7. ECOG 0-1

8. The expected survival is more than 3 months

9. The function of vital organs is normal (no blood components, cell growth factor drugs are allowed to be used within 14 days before the first medication)

10. Women of childbearing age need contraception

Exclusion Criteria:

1. The patient has any active autoimmune disease or a history of autoimmune disease

2. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment

3. Patients who have progressed after receiving second-line or above anti-vascular drug therapy in the past, or patients who have received immunotherapeutic drugs such as PD-1 / PD-L1 monoclonal antibody

4. Have received HAIC treatment in the past

5. Severe allergic reaction to other monoclonal antibodies

6. People with known history of central nervous system metastasis or hepatic encephalopathy

7. Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past

8. Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except for those with only a small amount of ascites on imaging but no clinical symptoms

9. Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg)

10. Have uncontrolled clinical symptoms or diseases of the heart

11. Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin

12. Have had significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before randomization

13. Arterial/venous thrombosis events that occurred within 6 months before randomization

14. Known hereditary or acquired bleeding and thrombotic tendency

15. Urine routine test showed urine protein = ++ and confirmed 24-hour urine protein content> 1.0 g

16. Patients who have previously received chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication; molecular targeted therapy (including other oral targeted drugs used in clinical trials) is less than 5 drugs from the first study medication Patients whose half-life or adverse events (except alopecia) caused by previous treatment have not recovered to = CTCAE Grade 1

17. The patient has active infection, fever of unknown origin within 7 days before medication =38.5?

18. Patients with congenital or acquired immune deficiencies

19. The patient has suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)

20. Patients with bone metastases who received palliative radiotherapy in the 4 weeks before participating in the study >5% of the bone marrow area

21. Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Drug:
• Camrelizumab
Each infusion is 30 min (not less than 20 min, not more than 60 min), once every 3 weeks
• HAIC
A chemotherapy regimen perfused through the tumor supplying artery, d1-2 administration, perfused every 4 weeks
• TKI
Lenvatinib or Regorafenib

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Yue Han	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (according to mRECIST)	Time from the first tumor progression or death	Up to two years
Secondary	Objective response rate (according to mRECIST and RECIST 1.1)	Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time (mainly for solid tumors), including complete remission (CR, Complete Response) and partial remission (PR, Partial Response)	Up to two years
Secondary	Disease control rate (according to mRECIST and RECIST 1.1)	Refers to the proportion of patients whose tumors have shrunk or been stable for a certain period of time (mainly for solid tumors), including complete remission (CR, Complete Response), partial remission (PR, Partial Response) and stable (SD, Stable Disease)	Up to two years