Surgery combined with immunotherapy and targeted therapy for advanced liver cancer

Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb Hepatocellular Carcinoma

This study is testing whether combining surgery with two treatments, camrelizumab and apatinib, can help people with advanced liver cancer live longer and feel better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangxi Medical University (Academic / other)
• Drugs / interventions: atezolizumab, nivolumab, pembrolizumab, tislelizumab, toripalimab, sintilimab, camrelizumab, chemotherapy, apatinib, Carrelizumab, atzuzumab, bevacizumab
• Locations: 1 site (Nanning)
• Trial ID: NCT05062837 on ClinicalTrials.gov

What this trial studies

This study aims to enroll patients with CNLC stage IIIb hepatocellular carcinoma (HCC) who have extrahepatic metastasis and intrahepatic lesions that can be surgically removed. Participants will undergo hepatectomy in combination with the immunotherapy drug camrelizumab and the targeted therapy apatinib. The study will evaluate various outcomes including overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to progression (TTP), and progression-free survival (PFS). The goal is to determine the efficacy and safety of this combined treatment approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with CNLC stage IIIb HCC and extrahepatic metastasis who are eligible for radical liver surgery.

Not a fit: Patients with brain metastasis or those who are unwilling to undergo surgery or other treatments like TACE or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced liver cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of immunotherapy and targeted therapy in advanced HCC, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥18
* CNLC stage IIIb HCC with extrahepatic metastasis (such as lymph node, lung, bone metastasis, but not brain metastasis) diagnosed by clinical imaging, and at least one measurable metastasis can be used as RECIST V1.1 to observe the objective efficacy of "targeted + immune" therapy on target lesions;
* Local tumors of the liver are expected to be radically resected;
* Liver function Child-Pugh grade A;
* ICG R15 \< 10%;
* ECOG PS 0 or 1 score;
* Estimated survival time ≥6 months;
* Hematological indexes should meet the following conditions: hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5×109/L; Platelet ≥80×109/L; Total bilirubin ≤1.5×ULN; ALT 3 x ULN or less;AST 3 x ULN or less; Alkaline phosphatase (AKP) ≤2.5×ULN; Serum albumin ≥28 g/L; Serum creatinine ≤1.5×ULN;
* The patient is unwilling to receive TACE or radiotherapy;
* For women of childbearing age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) should be used during the clinical trial until 3 months after the clinical trial ends; Serum or urine HCG test was negative for women of childbearing age within 72 hours prior to study enrollment. Effective contraception should be used during the study period and for three months after the end of the study for male patients with fertile partners.

Exclusion Criteria:

* Have a history or concurrence of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
* Have used or are currently using other immunosuppressive or chemotherapy drugs for HCC (including but not limited to atezolizumab, nivolumab, pembrolizumab, tislelizumab, toripalimab, sintilimab, camrelizumab, S-1, etc.);
* Patients who have received TACE, radiotherapy or systemic therapy within the past 6 months;
* The presence of congenital or acquired immune deficiency diseases (such as HIV positive);
* Known severe allergic reactions to PD-1 mab;
* Within 7 days of enrollment, body temperature of unknown etiology ≥ 38.5℃ or white blood cell count \> 15 x 109/L;
* Patients with hemorrhagic diseases (including but not limited to moderate/severe esophagogastric varices, gastrointestinal bleeding, hemorrhagic gastric ulcer, hemoptysis \> 2.5 ml per day) within 3 months of enrollment;For cases with positive occult blood in stool, occult blood should be reexamined, and gastroenteroscopy should be performed if necessary);
* Arterial or venous thrombosis, such as cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction, etc.), deep venous thrombosis and pulmonary infarction, etc., 6 months before enrollment;
* Those who have a history of alcohol or psychotropic drug abuse and cannot get rid of it or have mental disorders;
* Breast-feeding women;
* Autoimmune diseases in active stage or previous autoimmune diseases (such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, etc.);
* Were using immunosuppressant or hormone therapy 2 weeks before enrollment;
* Grade 1 CTCAE was not recovered after less than 5 drug half-lives with the last use of molecular targeted therapy or due to adverse events caused by previous therapy;
* Complicated with hepatic encephalopathy or brain metastasis;
* Hypertension beyond drug control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
* Uncontrolled heart disease or symptoms (including but not limited to grade II or higher cardiac function, unstable angina, myocardial infarction in the past 1 year, supraventricular or ventricular arrhythmias requiring treatment or intervention);
* Abnormal coagulation function (INR \> 2.0, PT \> 16 s), bleeding tendency or need thrombolytic therapy or anticoagulant therapy (but prophylactic use of low-dose aspirin or low-molecular weight heparin is permitted);
* Hereditary or acquired blood diseases (such as hemophilia, thrombocytopenia, coagulation disorders, etc.);
* Urine protein ≥ ++ and 24-hour urine protein ≥ 1.0g in routine urine tests.

Where this trial is running

Nanning

• Guangxi Medical University Cancer Hospital — Nanning, China (Recruiting)

Study contacts

• Principal investigator: Bang-De Xiang, Ph.D — Guangxi Medical University Cancer Hospital
• Study coordinator: Bang-De Xiang, Ph.D

Conditions Hepatocellular Carcinoma