mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

  • STATUS
    Recruiting
  • End date
    Jul 31, 2026
  • participants needed
    35
  • sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Updated on 13 June 2022

Summary

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

Details
Condition Stage III Hepatocellular Cancer (CNLC Staging)
Treatment mFOLFOX7+Camrelizumab+Apatinib
Clinical Study IdentifierNCT05412589
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients volunteered to participate in this study and signed informed consent
Age 18-75, male or female
ECOG PS score 0-2
Child-pugh liver function grading: Grade A or B
The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to stage III according to China liver cancer staging (CNLC)
Did not received any type of other first-line drugs such as Sorafenib
According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments)
Expected survival ≥ 12 weeks
The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days)
Blood routine
White blood cells count ≥3.0×109/L Platelet count ≥70×109/L Hemoglobin ≥80g/L
Liver and kidney function
Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or
creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin
(TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤
times the upper limit of normal value (ULN)
Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period
Subjects have good compliance and cooperate with the follow-up
Subjects with HBV or HCV infection should receive anti-virus treatment without interfron

Exclusion Criteria

Have received immunotherapeutic drugs or interferon in the past
Severe allergic reaction to other monoclonal antibodies
Female subjects with pregnancy
Patients with congenital or acquired immune deficiencies
Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin
The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
The patient has active infection, fever of unknown origin within 7 days (CTCAE>2)
Patients with congenital or acquired immune deficiencies
With clinical symptoms or diseases of the heart that are not well controlled
According to the judgment of the investigator, the patients with factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients
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