Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06607107

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

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-09-23

29

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

Sponsors

S

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

Lead Sponsor

J

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically, cytologically, or clinically diagnosed hepatocellular carcinoma at BCLC stage A or B exceeding Milan criteria
  • Child-Pugh liver function Grade A or B
  • No prior treatment with first-line drugs like Sorafenib or Lenvatinib
  • At least one measurable lesion by CT scan (diameter ≥10 mm) untreated by local therapies
  • ECOG performance status score between 0 and 2
  • Expected survival of at least 12 weeks
  • Adequate blood counts: white blood cells ≥3.0×10^9/L, platelets ≥70×10^9/L, hemoglobin ≥80 g/L without recent transfusion
  • Kidney function with serum creatinine ≤1.5 times upper normal limit
  • Liver function with total bilirubin and AST/ALT ≤1.5 and 3 times upper normal limits respectively
  • For hepatitis B or C coinfection, antiviral treatment required without interferon use
  • Women of childbearing age must have a negative pregnancy test within 7 days before enrollment, not be breastfeeding, and agree to contraception during and 6 months after the study; men must agree to contraception during and 6 months after the study
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Previous use of immunotherapy or interferon
  • Allergy to study drugs
  • Pregnancy or breastfeeding
  • Prior treatment with PD1/PDL1 targeting immunotherapy
  • Uncontrolled cardiac conditions including heart failure above NYHA class II, unstable angina, myocardial infarction within 1 year, significant arrhythmias needing intervention, or poorly controlled hypertension
  • History of other cancers except cured basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid cancer
  • Severe infections (grade 3 or higher), active pulmonary inflammation, or recent need for antibiotics (excluding prophylaxis)
  • History of immunodeficiency, organ or bone marrow transplantation, or use of immunosuppressive drugs (except certain mild conditions)
  • Severe blood clotting disorders or bleeding tendencies
  • History of drug abuse or mental disorders, brain metastases, or hepatic encephalopathy
  • Other serious diseases or abnormal labs posing safety risks or interfering with study data collection as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

L

linhui Peng, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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