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

NCT05135364 | Unknown Phase 2

• 1 other identifier: NCC3153
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Unresectable; TACE Failure; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (according to mRECIST)

  Time from the first tumor progression or death

  Up to two years

Secondary Outcomes (2)

• Objective response rate (according to mRECIST and RECIST 1.1)

  Up to two years

• Disease control rate (according to mRECIST and RECIST 1.1)

  Up to two years

Study Arms (1)

Camrelizumab+HAIC+TKI*

EXPERIMENTAL

\*For patients who have not received molecular targeted therapy in the past, lenvatinib is recommended; For patients who have received sorafenib or lenvatinib in the past, regorafenib is recommended.

Drug: Camrelizumab; Drug: HAIC; Drug: TKI

Interventions

Camrelizumab DRUG

Each infusion is 30 min (not less than 20 min, not more than 60 min), once every 3 weeks

Camrelizumab+HAIC+TKI*

HAIC DRUG

A chemotherapy regimen perfused through the tumor supplying artery, d1-2 administration, perfused every 4 weeks

Camrelizumab+HAIC+TKI*

TKI DRUG

Lenvatinib or Regorafenib

Camrelizumab+HAIC+TKI*

Eligibility Criteria

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

You may qualify if:

• Paticipants voluntarily joined the study and signed the informed consent form
• Above 18 years old, both male and female
• Clinical diagnosis or histopathologically confirmed advanced hepatocellular carcinoma (unresectable)
• Child-Pugh score ≤ 7
• BCLC B and C
• TACE failure: ① 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; ② extrahepatic metastasis or vascular invasion; ③ postoperative tumor indicators continue to rise (even if there is a short-term decline)
• ECOG 0-1
• The expected survival is more than 3 months
• 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)
• Women of childbearing age need contraception

You may not qualify if:

• The patient has any active autoimmune disease or a history of autoimmune disease
• 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
• 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
• Have received HAIC treatment in the past
• Severe allergic reaction to other monoclonal antibodies
• People with known history of central nervous system metastasis or hepatic encephalopathy
• Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past
• 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
• Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
• Have uncontrolled clinical symptoms or diseases of the heart
• 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
• Have had significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before randomization
• Arterial/venous thrombosis events that occurred within 6 months before randomization
• Known hereditary or acquired bleeding and thrombotic tendency
• Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein content\> 1.0 g

Sponsors & Collaborators

• Yue Han: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab

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

• yue Han, phD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yue Han, phD

CONTACT

13511021629; doctorhan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 26, 2021
• Study Start: November 5, 2021
• Primary Completion: October 5, 2022
• Study Completion: December 5, 2024
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

CN (1)