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ANGIO-A: Oral Cyclophosphamide and Sorafenib with Intravenous Bevacizumab and Atezolizumab in Pediatric Solid Tumor Patients

Trial snapshot

  • Formal name: ANGIO-A: Safety and Tolerability of Oral Cyclophosphamide and Sorafenib with Intravenous Bevacizumab with the Addition of Atezolizumab in Pediatric Solid Tumor Patients
  • Trial type: Includes fibrolamellar carcinoma
  • Phase: Phase I / II
  • Recruitment status: Active, Recruiting
  • Eligible ages: less than 30 years old at time of enrollment
  • Location: Memphis, TN (St. Jude Children’s Research Hospital)
  • ClinicalTrials.gov ID: NCT05468359

Overview

This is phase I/II clinical trial being at St. Jude Children’s Research Hospital is testing a four-drug combination in children, adolescents, and young adults with rare solid tumors that have come back after treatment or have not responded to treatment. The study includes a focus on FLC.

The treatment combines:

  • Cyclophosphamide (chemotherapy)
  • Sorafenib (a targeted therapy)
  • Bevacizumab (Avastin) (blocks tumor blood vessels)
  • Atezolizumab (Tecentriq) (an immunotherapy drug)

Researchers believe these drugs may work better together than alone:

  • Sorafenib and bevacizumab may help slow tumor growth and reduce the blood supply to tumors.
  • Atezolizumab, an immune checkpoint inhibitor, may help the immune system recognize and attack cancer cells. Cancer cells often protect themselves by using a molecular “off switch” called PD-L1. Atezolizumab is an antibody that blocks PD-L1, preventing the tumor from sending a “don’t attack me” signal. This can allow T cells to become more active against cancer cells.
  • Low-dose cyclophosphamide may help change the tumor environment in ways that make immunotherapy work better.

Trial details and eligibility

This trial has two parts:

  • Part 1: Safety Study (Phase I)
    Researchers first enroll patients with various relapsed or refractory solid tumors to determine whether the four-drug combination can be given safely and the best dose of sorafenib when drug levels are adjusted based on blood tests (“PK-guided dosing”).
  • Part 2: Activity Study (Phase II)
    After the safest dosing plan is identified, researchers study how well the treatment works, particularly in patients with FLC, HCC, desmoplastic small round cell tumor, and other rare solid tumors. The study aims not only to see whether tumors shrink, but also to understand how the treatment affects the immune system and tumor biology.

During the trial, patients will receive treatment in 21-day cycles:

  • Cyclophosphamide: taken by mouth daily for 21 days.
  • Sorafenib: taken by mouth daily, with dose adjustments based on blood levels.
  • Bevacizumab: intravenous infusion every 3 weeks.
  • Atezolizumab: intravenous infusion every 3 weeks.

To participate, patients must:

  • Be under 30 years old.
  • Have a relapsed or refractory solid tumor.
  • Have disease that can be biopsied.
  • Have adequate organ function and be healthy enough for treatment.

The principal Investigator for the effort is Jessica Gartrell, MD. For details can be found at: https://clinicaltrials.gov/study/NCT05468359.

What makes this trial interesting for FLC patients?

For many FLC patients, currently available treatments have limited effectiveness once the disease becomes unresectable or recurs.This study is one of the few prospective trials designed specifically to evaluate a combination of:

  • anti-angiogenic therapy (blocking tumor blood vessels),
  • targeted therapy,
  • chemotherapy, and
  • immunotherapy.

In addition, it is conducted at the St. Jude Children’s Research Hospital, a leading pediatric cancer research center that never bills families for treatment. This allows parents to focus on their child’s care rather than the financial burden of illness.

Trial contact information

For more information about this trial, visit: https://clinicaltrials.gov/study/NCT05468359.

Please visit clinicaltrials.gov for a comprehensive list of active trials. 

The Fibrolamellar Cancer Foundation does not provide medical advice.  We provide website users with information to help them better understand their health conditions and current approaches towards diagnosis, treatment and supportive care. Always seek the advice of your physician or other qualified healthcare provider.