Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05412589

mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-07-31

35

Participants Needed

1

Research Sites

216 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma

CONDITIONS

Official Title

mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients volunteered to participate and signed informed consent
  • Age 18-75 years, male or female
  • ECOG performance status score of 0-2
  • Child-Pugh liver function grade A or B
  • Diagnosis of primary hepatocellular carcinoma stage III by CNLC staging
  • No prior treatment with first-line drugs like Sorafenib
  • At least one measurable lesion by CT or MRI scan (≥10mm long diameter or ≥15mm short diameter for lymph nodes), untreated by local therapies
  • Expected survival of at least 12 weeks
  • Vital organ function within specified limits: white blood cells ≥3.0×10^9/L, platelets ≥70×10^9/L, hemoglobin ≥80g/L; serum creatinine ≤1.5× upper normal or creatinine clearance ≥50 ml/min; total bilirubin ≤1.5× upper normal; AST or ALT ≤3× upper normal
  • Women of childbearing age agree to use contraception during and for 6 months after treatment; negative pregnancy test within 7 days before inclusion; males agree to use contraception during and 6 months after study
  • Good compliance and willingness to follow-up
  • If infected with HBV or HCV, receiving antiviral treatment excluding interferon
Not Eligible

You will not qualify if you...

  • Prior immunotherapy or interferon treatment
  • Severe allergic reactions to monoclonal antibodies
  • Pregnancy
  • Congenital or acquired immune deficiencies
  • Abnormal blood clotting (INR>2.0, PT>16s), bleeding tendencies, or on thrombolytic/anticoagulant therapy except preventive low-dose aspirin or heparin
  • Other active cancers except cured skin basal cell carcinoma or cervical carcinoma in situ
  • Active infections or fever of unknown cause within 7 days with CTCAE grade >2
  • Uncontrolled heart disease symptoms
  • Factors causing likely study termination such as alcoholism, drug abuse, serious diseases including mental illness, severe lab abnormalities, or social/family issues affecting safety

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

Y

Yunxiuxiu Xu, MD

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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