mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

NCT ID: NCT05412589

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2026-07-31

Brief 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

Detailed Description

The combination of anti-angiogenesis and immune checkpoint blockade showed promising outcomes for advanced HCC. Hepatic artery infusion chemotherapy （HAIC） combined with apatinib and camrelizumab could augment treatment efficacy in preliminary study. But HAIC had disadvantages such as technical limitations, expensive cost and poor patient comfort. In the present study, we aimed to investigate the efficacy and safety of Venous Infusion Chemotherapy（VIC） plus camrelizumab and apatinib for CNLC stage Ⅲ HCC.

Conditions

Stage III Hepatocellular Cancer (CNLC Staging)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

mFOLFOX7+Camrelizumab+Apatinib

Intervention Type: DRUG

Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle.

Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg，po，qd for every 21 days

Interventions

mFOLFOX7+Camrelizumab+Apatinib

Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle.

Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg，po，qd for every 21 days

Intervention Type: DRUG

Other Intervention Names

Combination Product: Systemic chemotherapy combined with Apatinib and Camrelizumab

Eligibility Criteria

Inclusion Criteria

1. Patients volunteered to participate in this study and signed informed consent;

2. Age 18-75, male or female;

3. ECOG PS score 0-2;

4. Child-pugh liver function grading: Grade A or B

5. The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to stage III according to China liver cancer staging (CNLC)

6. Did not received any type of other first-line drugs such as Sorafenib

7. 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);

8. Expected survival ≥ 12 weeks;

9. 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)

10. 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.

11. Subjects have good compliance and cooperate with the follow-up.

12. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron.

Exclusion Criteria

1. Have received immunotherapeutic drugs or interferon in the past.

2. Severe allergic reaction to other monoclonal antibodies.

3. Female subjects with pregnancy.

4. Patients with congenital or acquired immune deficiencies.

5. 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

6. The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)

7. The patient has active infection, fever of unknown origin within 7 days (CTCAE>2)

8. Patients with congenital or acquired immune deficiencies.

9. With clinical symptoms or diseases of the heart that are not well controlled.

10. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

linhui Peng, Prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunxiuxiu Xu, MD

Role: CONTACT

xuyxx@mail.sysu.edu.cn

17722864609

Facility Contacts

Yunxiuxiu Xu, MD

Role: primary

xuyxx@mail.sysu.edu.cn

17722864609

Other Identifiers

SYSKY-2021-KY-139

Identifier Type: -

Identifier Source: org_study_id