A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma

NCT06363825 | Recruiting Phase 2

• 1 other identifier: MRCTA,ECFAH Of FMU[2024]373
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load

Conditions

Advanced Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; high tumor load; camrelizumab; apatinib; HAIC; TAE

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation.

  1 years

Secondary Outcomes (5)

• Disease control rate (DCR)

  1 years

• Progression-free survival (PFS)

  1 years

• Tumor progression time (TTP)

  1 years

• Overall survival (OS)

  3 years

• AE

  1 years

Study Arms (1)

Single arm

EXPERIMENTAL

TAE+HAIC combined with camrelizumab and apatinib

Drug: camrelizumab

Interventions

camrelizumab DRUG

TAE: 3-15ml iodized oil; HAIC: Indurating arterial catheter, oxaliplatin 85mg/m\^2 D1, arterial infusion, lasting 1-2 hours (d1), LV 400mg/m\^2, arterial infusion, lasting 2-3 hours (d1), 5-Fu 400mg/m\^2, arterial infusion, lasting 3 hours (d1), and fluorouracil 2400 mg/m\^2 for 24-48h; camrelizumab: 200mg, ivgtt, 30 min (not less than 20 min, not more than 60 min) every 3 weeks (21 days); apatinib mesylate: 250mg, once a day, taken orally (the time of daily administration should be as much as possible), with warm water.Stop for 3 days before next cycle intervention. Camrelizumab was given intravenously 1 day before TAE+HAIC treatment for each cycle, TAE+HAIC treatment was given on the second day, and oral apatinib was started after discharge.

Also known as: apatinib

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The subjects voluntarily joined the study, had good compliance, cooperated with follow-up, and obtained written informed consent;
• \. Age: 18 years old ≤80 years old, both male and female;
• \. In accordance with the "Norms for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition)" formulated by the National Health Commission and the 2018 EASL liver Cancer guidelines formulated by the European Association for the Study of Hepatology, a definite diagnosis of hepatocellular carcinoma has been made and pathological results have been obtained;
• \. There is at least one measurable lesion (spiral CT scan diameter ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard, see Annex 5 for RECIST version 1.1);
• \. Have not received systematic treatment before;
• CNLC was divided into stages Ⅱa-Ⅲb;
• \. Meet the status of high tumor load, and meet one of the following conditions: 1) High tumor load is defined according to the 7-11 criteria: combined with the number of tumors and the maximum tumor size, high tumor load is defined as and \> 11; 2) Combined with primary branch of portal vein and main cancer thrombus;
• \. The Child-Pugh classification of liver function is grade A or B (5-8 points);
• ECOG PS score 0-1;
• \. Expected survival ≥12 weeks;
• \. If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA≤2000, treatment can be started directly; If HBV-DNA \> 2000, start antiviral therapy for one week and then start treatment.
• \. The major organs function properly and meet the following criteria:
• The standard of blood routine examination must meet: (no blood transfusion within 14 days)
• Hemoglobin (HB) ≥100g/L,
• White blood cell count (WBC)≥3×10\^9/L

You may not qualify if:

• \. Pregnant or lactating women;
• \. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ);
• \. Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
• \. Patients who have participated in other clinical trials in the past three months;
• \. Received local treatment (such as surgical resection, radiation therapy, ablative therapy, interventional therapy, etc.) within the past 1 month;
• \. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, except portal vein thrombosis, occurred within 6 months prior to the first dose of the study drug;
• \. Immunosuppressants or systemic hormone therapy (dose \>10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression;
• \. Esophageal (fundus) varices rupture and bleeding within 1 month before treatment;
• \. Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding; Platelet count \< 50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy);
• \. Refractory ascites, bad fluid;
• \. Active infection, especially inflammation of the biliary system;
• \. Severe liver, kidney, heart, lung, brain and other major organ failure;
• \. Previous use of targeted drugs, any component of PD-1 MAB or other similar tests A quick person;
• \. Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
• \. Previous serious cardiovascular disease, including but not limited to the following diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms in men and ≥470 ms in women); According to NYHA criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 50% indicated by cardiac color ultrasound;

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Xinhua Chen

Fuzhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab; apatinib

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

• Zhong Tang

  Nanping First Hospital of Fujian Province

  PRINCIPAL INVESTIGATOR

• Yingchun Li

  Longyan First Hospital, Affiliated to Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Peishu Huang

  Shanghai Sixth Hospital Fujian Hospital

  PRINCIPAL INVESTIGATOR

• Lei Yu

  Sanming First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiping Chen

CONTACT

13805066904; ptchenyp@163.cm

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: Associate professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: April 12, 2024
• Primary Completion: April 11, 2026
• Study Completion (Estimated): May 11, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)