RecruitingPhase 2NCT06607107

mFOLFOX7 Plus Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria

A Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Systemic Chemotherapy(mFOLFOX7) Combined With Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

29 participants

Start Date

Feb 17, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

Summary

This study was designed to evaluate the effectiveness and safety of mFOLFOX7（Oxaliplatin,Calcium Levofolinate,Fluorouracil） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma. The primary outcome measure is to evaluate the primary pathological response (MPR) rate of the therapy for Hepatocellular Carcinoma. The secondary Outcome measures include the objective response rate (ORR), the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS) of the therapy for Hepatocellular Carcinoma. Moreover, this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chemotherapy (mFOLFOX7), an immunotherapy drug (camrelizumab), and a targeted therapy (apatinib) for people with liver cancer (hepatocellular carcinoma) that is too large or has spread too far for a liver transplant (beyond Milan criteria), but has not yet received any systemic drug treatment. **You may be eligible if...** - You have been diagnosed with liver cancer (HCC) at BCLC stage A or B that exceeds transplant criteria - You have not received any prior systemic treatments like sorafenib or lenvatinib - Your liver function is classified as Child-Pugh Grade A or B - You have at least one measurable lesion on imaging - You are in reasonable health (ECOG performance score 0–2) - Your expected survival is at least 12 weeks - Your blood counts and organ function meet minimum thresholds **You may NOT be eligible if...** - You have already received other first-line systemic treatments - Your organ function does not meet the study's requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFOX7 combined with Camrelizumab and apatinib

mFOLFOX7(Oxaliplatin 85mg/m2, Calcium Levofolinate 200mg/m2, Fluorouracil 400 mg/m2 D1，2400mg/m2 maintain 46 hours，) combined with Apatinib and Camrelizumab 200mg every 3 weeks. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally after meals, once a day, for continuous medication.