Combination Chemoembolization and Stereotactic Body Radiation Therapy in Unresectable Hepatocellular Carcinoma

NCT02513199 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 14-1671
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop better ways to treat liver cancer, known as hepatocellular carcinoma or HCC, while it is still in the liver. Many treatments exist to treat tumors in the liver when they are small but after they grow past a certain size, local therapies such as surgery, Trans-Arterial Chemo Embolization (TACE), or Radiofrequency Ablation (RFA) are not effective. The purpose of this study to test the combination of two known treatments - TACE and Stereotactic Body Radiation Therapy (SBRT) - to be used together to treat larger or difficult to access liver tumors. Each treatment has been shown to work well but has limitations. The study will combine the treatments in an organized sequence and monitor closely how effective this combination controls tumors.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Trans-Arterial Chemoembolization; Stereotactic Body Radiation Therapy; HCC; TACE; SBRT

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Objective Response Rate

  Tumor response will be assessed using mRECIST criteria as well diffusion weight imaging (DWI) via Magnetic Resonance Imaging (MRI) surveillance. * Complete response (CR): Disappearance of all target lesions * Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started * Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

  up to 72 months

Secondary Outcomes (5)

• Time to CR

  up to 72 months

• Time to Progression (TTP)

  up to 80 months

• Number of Participants With Overall Survival (OS)

  2 years

• Progression Free Survival (PFS)

  up to 72 months

• Change in Child-Turcotte-Pugh (CTP) Score

  3 months

Study Arms (1)

Participants with HCC

EXPERIMENTAL

Participants with HCC with a lesion greater than 3 cm treated with TACE/SBRT combination

Radiation: SBRT; Drug: TACE

Interventions

SBRT RADIATION

Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days.

Also known as: Stereotactic Body Radiation Therapy

Participants with HCC

TACE DRUG

two sessions of standard TACE with ethiodol separated by a 4-week interval.

Also known as: Trans-Arterial Chemoembolization

Participants with HCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be diagnosed with HCC either pathologically or by the American Association for the Study of Liver Diseases (AASLD) radiographic criteria (Bruix Hepatology 2011). The criteria specifies CT or MRI intense arterial uptake followed by "washout" of contrast in the venous-delayed phases. Any atypical lesions must be confirmed by biopsy.
• A single liver lesion with tumor size ≥ 3 cm as defined as maximal diameter in the axial dimension on MRI. Included in the measurement are both enhancing and non-enhancing components of the lesion.
• Maximum tumor size of 7 cm as defined as maximal diameter in the axial dimension on MRI.
• Age ≥ 18 years
• Child-Pugh class A or B7 without ascites
• ECOG score 0
• No prior treatment of current HCC. However, recurrent HCC after resection may be included.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Pregnancy which will be assessed via pregnancy test prior to TACE and repeated prior to SBRT.
• Metastatic disease outside of the liver
• Vascular invasion as evidenced by vessel occlusion or radiographic evidence of tumor thrombus.
• Contraindications to MRI, including claustrophobia, metallic implants, and pacemakers
• Tumor for which adequate radiation dosage cannot be safely delivered (see dose constraints below)
• Prior therapeutic radiation therapy to the abdomen and/or lower thorax as defined as below the carina to the pelvic inlet.
• Inability to provide informed consent based on persistent lack of understanding, inability to find adequate translation, impaired mental status such as mental retardation, drug induced, or traumatic brain injury.
• Multiple liver tumors making the patient a BCLC Stage B
• Prior treatment, except for surgical resection, to the lesion being targeted in the protocol.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Buckstein M, Kim E, Ozbek U, Tabrizian P, Gunasekaran G, Facciuto M, Rosenzweig K, Llovet JM, Schwartz M. Combination Transarterial Chemoembolization and Stereotactic Body Radiation Therapy for Unresectable Single Large Hepatocellular Carcinoma: Results From a Prospective Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2022 Oct 1;114(2):221-230. doi: 10.1016/j.ijrobp.2022.05.021. Epub 2022 May 26.

  PMID: 35643250 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Michael Buckstein
• Organization: Icahn School of Medicine at Mount Sinai

michael.buckstein@mountsinai.org

212-241-7502

Study Officials

• Michael Buckstein, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: July 31, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: June 18, 2023
• Results First Posted: June 18, 2023

Record last verified: 2023-05

Locations

US (1)