Combining Fruquintinib and Sintilimab with TACE for Liver Cancer

Phase II Study of Fruquintinib Combined With Sintilimab and TACE for Inoperable Primary Hepatocellular Carcinoma

This study is testing a new combination of two drugs with a type of chemotherapy to see if it can help people with inoperable liver cancer live longer without their disease getting worse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: sintulimab, fruquintinib, Sintilimab, pembrolizumab, lenvatinib, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05971199 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of fruquintinib combined with sintilimab and transcatheter arterial chemoembolization (TACE) in patients with inoperable primary hepatocellular carcinoma (HCC). The study aims to improve progression-free survival (PFS) for patients who cannot undergo surgical treatment. Participants will be monitored for their response to this combination therapy, which is based on previous findings that suggest enhanced outcomes with combination treatments for HCC. The trial is designed to gather data on the safety and efficacy of this novel approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with diagnosed primary hepatocellular carcinoma who are unable to undergo surgical treatment.

Not a fit: Patients with Child-Pugh liver function rating worse than grade B or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly extend the progression-free survival of patients with inoperable liver cancer.

How similar studies have performed: Previous studies have shown promising results with combination therapies for HCC, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years, male or female;
2. Patients diagnosed with primary hepatocellular carcinoma (HCC) based on clinical diagnosis or pathology;
3. Patients diagnosed with Chinese stage IIb-IIIa according to the Primary Liver Cancer Diagnostic and Treatment Protocol (2019 version), and evaluated by the investigator to be unable to undergo surgical treatment, such as resection, ablation or liver transplantation;
4. Imaging reports within 14 days prior to the intervention showed the presence of at least 1 target lesion measurable by CT or MRI, and the lesion is suitable for repeated accurate measurements;
5. Child-Pugh liver function rating: grade A or better B (≤7 points);
6. ECOG score: 0-1;
7. all lesions amenable to phase 1 or 2 (fractionated TACE) TACE therapy;
8. Good organ and bone marrow function. Blood count: WBC\>4. 0 × 109/L, Hb\>80g/L, PLT\>75 ×109/L, NEUT\>/ 1.5 × 109/L; coagulation function:International normalized (prothrombin time) ratio(INR) \<1.2; liver function indexes: serum albumin (ALB) \>3.5 g/dl, serum total bilirubin(TBIL) \<1.5 times the upper limit of normal value (excluding biliary obstruction), serum transaminases (ALT and AST)\<3 times the upper limit of normal value; renal function: serum myelin (CR) \<1.5 times the upper limit of normal value;
9. Patients with positive hepatitis B surface antigen need to have received anti-hepatitis B treatment prior to inclusion in the study;
10. Signed an informed consent form, were compliant and cooperated with the follow-up.

Exclusion Criteria:

1. Hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibrous lamellar hepatocellular carcinoma;
2. With portal trunk or vena cava invasion;
3. Having received interventional treatment such as TACE within 2 years
4. Combined with medical contraindications that preclude any contrast-enhanced imaging (CT or MRI);
5. Previous systemic therapy;
6. Uncontrollable ascites, hepatic encephalopathy or bleeding esophagogastric fundic varices;
7. Hypertension that cannot be reduced to within normal limits with antihypertensive medication (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg);
8. Suffering from myocardial ischemia or myocardial infarction of grade II or higher, poorly controlled arrhythmia of grade II or higher myocardial ischemia or infarction, poorly controlled arrhythmia (QTc interval greater than or equal to 450 ms, QTc interval calculated in Fridericia metric).

   (calculated in Fridericia formula);
9. History of gastrointestinal bleeding within the past 3 months or a clear tendency of gastrointestinal bleeding, such as: esophageal varices at risk of bleeding, locally active ulcer lesions, fecal occult blood (++);
10. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraceptive measures
11. HIV-infected patients;
12. Those suspected of being allergic to the study drug;
13. Other circumstances that, in the judgment of the investigator, may affect the conduct of the clinical study and the determination of the study results.

Where this trial is running

Hangzhou, Zhejiang

• Guoliang Shao — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Guoliang Shao — Zhejiang Cancer Hospital Hangzhou, Zhejiang, China
• Study coordinator: Guoliang Shao

Conditions Hepatocellular Carcinoma