Hepatic Arterial Infusion Combined With Lenvatinib and Camrelizumab for Unresectable Hepatocellular Carcinoma

NCT05003700 | Completed Phase 2

• 1 other identifier: NFEC-2020-130
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin and raltitrexed plus lenvatinib and camrelizumab in patients with unresectable hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1

  From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

Secondary Outcomes (7)

• The disease control rate (DCR)

  From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

• Duration of response (DOR)

  From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)

• Progression free survival rate at 12 months

  From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)

• Overall survival rate at 12 months

  From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)

• The median progression free survival time (mPFS)

  From date of first dose of study drug to the date of first documentation of disease progression (up to approximately 3 years)

Study Arms (1)

HAIC(RALOX) plus Lenvatinib and Camrelizumab

EXPERIMENTAL

Hepatic arterial infusion of oxaliplatin and raltitrexed every 3 weeks. Lenvatinib 8 mg once daily (QD) oral dosing. Camrelizumab 200mg intravenously every 3 weeks.

Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: Camrelizumab

Interventions

Hepatic arterial infusion chemotherapy PROCEDURE

administration of oxaliplatin and raltitrexed via the tumor feeding arteries every 3 weeks.

HAIC(RALOX) plus Lenvatinib and Camrelizumab

Lenvatinib DRUG

8 mg once daily (QD) oral dosing.

Also known as: Lenvima

HAIC(RALOX) plus Lenvatinib and Camrelizumab

Camrelizumab DRUG

200mg intravenously every 3 weeks.

HAIC(RALOX) plus Lenvatinib and Camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient voluntarily joins the study and signs an informed consent;
• Age ≥ 18 years old, ≤ 75 years old, both men and women;
• Clinical or pathologically confirmed BCLC B(tumor numbers≥4) or C-stage hepatocellular carcinoma, no further first-line treatment;
• At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary tumor burden;
• Child-Pugh score small or equal to 7 points (Child-Pugh A-B);
• The maximum liver tumor diameter ≥7cm;
• ECOG score: 0 to 1 (according to the ECOG score classification);
• The expected survival is longer than 12 weeks;
• The laboratory parameters meets the following requirements (no blood components and cell growth factors are allowed within 14 days before the first dose):
• Absolute neutrophil count ≥ 1.5 × 109 / L; Platelets ≥ 50 × 109 / L; Hemoglobin ≥ 80 g / L; serum albumin ≥ 28 g / L; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled); bilirubin ≤ 1.5 × ULN (within 7 days prior to the first dose); ALT ≤ 3 x ULN and AST ≤ 3 x ULN (within 7 days prior to the first dose); AKP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN;
• For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Camrelizumab injection.

You may not qualify if:

• The patient has any active auto-immune disease or a history of auto-immune disease;
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
• 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;
• Known central nervous system tumors including metastatic brain disease;
• Known history of HIV;
• History of organ allograft;
• Known or suspected allergy to the investigational agents or any agent given in association with this trial;
• Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥90 mmHg);
• Evidence of bleeding diathesis;
• Patients with clinically significant gastrointestinal bleeding within 3 months prior to study entry.
• Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
• 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);
• Urine routine indicates that urine protein ≥ ++ and 24-hour urine protein amount \> 1.0g was confirmed;
• The patient has active infection, unexplained fever (≥38.5 °C) within 3 days before administration, or baseline white blood cell count\>15×109/L;
• Patients with congenital or acquired immunodeficiency (such as HIV-infected patients);

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib; 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

• Jinzhang Chen

  Nanfang Hospital, Southern Medical University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 12, 2021
• Study Start: August 12, 2021
• Primary Completion: May 26, 2023
• Study Completion: July 4, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)