Intravenous mFOLFOX7 Plus Camrelizumab and Apatinib for CNLC Stage III Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 ≤ 3 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.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yunxiuxiu Xu, MD
xuyxx@mail.sysu.edu.cn
17722864609
Time Frame
Start Date: 2022-06-10
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 35
Treatments
Experimental: intravenous mFOLFOX7 combined with Camrelizumab and apatinib
Combination of systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (mFOLFOX7) , targeted drugs (Apatinib 250mg), and anti-PD-1 immunotherapy (Camrelizumab 200mg)
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov

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