Combination treatment for advanced liver cancer

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

This study is testing a new combination treatment for people with advanced liver cancer to see if it works better and is safer than current methods.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: Camrelizumab, apatinib, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05412589 on ClinicalTrials.gov

What this trial studies

This phase II clinical study investigates the efficacy and safety of a combination treatment involving intravenous mFOLFOX7, Camrelizumab, and Apatinib for patients with stage III hepatocellular carcinoma (HCC). The study aims to improve treatment outcomes by utilizing venous infusion chemotherapy instead of hepatic artery infusion, which has limitations such as high costs and patient discomfort. Participants will be monitored for their response to the treatment and any associated side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with stage III hepatocellular carcinoma who have not received prior first-line treatments.

Not a fit: Patients with severe liver dysfunction or those who have previously undergone first-line treatments like Sorafenib may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced liver cancer.

How similar studies have performed: Previous studies combining anti-angiogenesis and immune checkpoint blockade have shown promising outcomes, suggesting potential success for this approach.

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

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: linhui Peng, Prof — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Yunxiuxiu Xu, MD

Conditions Stage III Hepatocellular Cancer