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

November 22, 2021 updated by: Yue Han

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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: 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)
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (according to mRECIST)
Time Frame: Up to two years
Time from the first tumor progression or death
Up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (according to mRECIST and RECIST 1.1)
Time Frame: Up to two years
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
Disease control rate (according to mRECIST and RECIST 1.1)
Time Frame: Up to two years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yue Han

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: yue Han, phD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 5, 2021

Primary Completion (ANTICIPATED)

October 5, 2022

Study Completion (ANTICIPATED)

December 5, 2024

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (ACTUAL)

November 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC3153

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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