A Prospective, Single-arm, Phase II Trial to Evaluate the Effectiveness and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) of Oxaliplatin, 5-fluorouracil and Leucovorin (mFOLFOX7) Combined With Apatinib-Mesylate Tablets and Camrelizumab for Injection for C-staged Hepatocellular Carcinoma in BCLC Classification.

Who is this study for? Patients with C-staged Hepatocellular Carcinoma in BCLC Classification
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab (Triplet-combined Therapy) for C-staged Hepatocellular Carcinoma in BCLC classification. The primary outcome measure is to evaluate the objective response rate (ORR) of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification. The secondary Outcome measures include 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 Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification. Moreover, this study aims to assess the safety and tolerability of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• The patient voluntarily joins the study and signs an informed consent;

• Age ≥ 18 years old, ≤ 70 years old, both men and women;

• Clinical or pathologically confirmed BCLC C-stage hepatocellular carcinoma, no further first-line treatment;

• At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary tumor burden;

• Child-Pugh score small or equal to 7 points (Child-Pugh A-B);

• The liver tumor burden does not exceed 50% of the total liver volume;

• Patient can swallow tablet normally;

• ECOG score: 0 to 1 (according to the ECOG score classification);

• The expected survival is longer than 12 weeks;

⁃ The laboratory parameters meets the following requirements (no blood components and cell growth factors are allowed within 14 days before the first dose):

∙ Absolute neutrophil count ≥ 3.0 × 109 / L;

‣ Platelets ≥ 80 × 109 / L;

‣ Hemoglobin ≥ 90 g / L;

‣ serum albumin ≥ 28 g / L;

‣ Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled);

‣ bilirubin ≤ 1.5 × ULN (within 7 days prior to the first dose);

‣ ALT ≤ 3 x ULN and AST ≤ 3 x ULN (within 7 days prior to the first dose);

‣ AKP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN;

⁃ For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Camrelizumab injection.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yang-kui Gu, Prof.
guyk@sysucc.org.cn
13822197618
Backup
Tian-qi Zhang, Dr.
zhangtq@sysucc.org.cn
18620877505
Time Frame
Start Date: 2020-04-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 47
Treatments
Experimental: TRIPLET
Hepatic Arterial Infusion combined with Apatinib and Camrelizumab
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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