Not Yet RecruitingPhase 2

FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma

China30 participantsStarted 2025-06-30

Plain-language summary

Study Design: This is a pilot study with a single arm in a single centre assessing safety and efficacy of durvalumab in combination with bevacizumab and HAIC followed by SBRT. This study will be conducted in selected patients with intermediate or advanced stage HCC not amenable to curative therapy. Approximately 30 patients will be enrolled and receive treatments. Primary Objectives: To evaluate the possibility of HAIC plus durvalumab and bevacizumab followed by SBRT as conversion therapy for HCC. Secondary Objective(s): To evaluate the efficacy of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC. To evaluate the safety of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC. Exploratory Objective(s): Evaluate the consistency of imaging CR and pathological CR in resected patients, and explore biomarkers associated with prognosis .

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
✓. Age \> 18 years.
✓. Have a HCC diagnosis confirmed by radiology, histology, or cytology.
✓. HCC newly diagnosed or recurrent with a history of surgery or ablation, not amenable to curative surgery or transplantation.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to screening.
✓. Tumours were classified as unresectable after a multidisciplinary team review because either:
✓. R0 resection was not feasible

Exclusion criteria

What they're measuring

Conversion rate

Timeframe: 3 MONTH

Trial details

NCT IDNCT07012798

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Huikai Li

18622228633 tjchlhk@126.com

View on ClinicalTrials.gov More Hepatocellular Carcinoma (HCC) trials