TACE with bevacizumab for liver metastases

An Open-Label Pilot Study to Evaluate Efficacy and Safety of Bevacizumab Via Transarterial Chemoembolization (TACE) in Patients With Liver Metastases

This trial tests whether giving bevacizumab together with transarterial chemoembolization (TACE) helps people with unresectable liver metastases live longer and control liver tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Pardis Noor Medical Imaging and Cancer Center (Academic / other)
• Drugs / interventions: Bevacizumab, chemotherapy
• Locations: 1 site (Tehran, Tehran Province)
• Trial ID: NCT06311851 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm Phase 1/2 study will give patients with unresectable liver metastases transarterial chemoembolization (TACE) combined with bevacizumab. TACE delivers chemotherapy directly to liver tumors while blocking their blood supply, and bevacizumab is an anti‑VEGF antibody intended to inhibit new blood vessel growth. The study will enroll patients with good performance status and adequate liver function and will measure overall survival, tumor response, and safety. Because there is no randomized control arm, outcomes will be compared to historical expectations for similar patients.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable liver metastases, ECOG performance status 0–1, Child‑Pugh A or B liver function, hepatic tumor burden under 70%, and adequate blood and organ function.

Not a fit: Patients with active infection, severe comorbidities such as refractory ascites or hepatic encephalopathy, very poor liver function (Child‑Pugh C), very high liver tumor burden, or poor performance status are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could improve control of liver tumors and extend survival by enhancing local chemotherapy effects and limiting tumor blood vessel growth.

How similar studies have performed: TACE is an established locoregional therapy and systemic anti‑VEGF drugs like bevacizumab have shown activity in some metastatic cancers, but combining bevacizumab with TACE for liver metastases has not been previously reported.

Eligibility criteria

Inclusion Criteria:

* Confirmation of metastatic liver cancer via histological examination or a characteristic imaging profile on dynamic computed tomography (CT) scan or magnetic resonance imaging (MRI) without indications for surgical resection
* Eastern cooperative oncology group performance status (ECOGPS) of 0 or 1
* Liver function categorized as Child-Pugh class A or B
* Stable non-hepatic metastases, such as skeletal, pulmonary, or lymph node metastases
* Hepatic tumor burden below 70%
* Expected survival duration exceeding six months
* Laboratory findings meeting specific criteria, including platelet count \>50×109 /L, hemoglobin \>8.0 g/dL, ANC count ≥1.5 × 109/L, bilirubin \<51 mmol/L, alanine and aspartate aminotransferase \<3 times the upper limit of the normal range, and serum creatinine \<1.5 times the upper limit of the normal range.

Exclusion Criteria:

* Active infection
* Presence of severe comorbidities, such as hepatic encephalopathy, refractory ascites, and esophageal variceal bleeding
* Prior liver resection
* Previous TACE therapy received at other healthcare facilities
* Poor performance status (ECOGPS \> 1)

Where this trial is running

Tehran, Tehran Province

• Pardis Noor Medical Imaging and Cancer Center — Tehran, Tehran Province, Iran (Recruiting)

Study contacts

• Study coordinator: Shahram Akhlaghpoor, M.D

Conditions Cancer; Metastatic Cancer; Liver Metastases