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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07012798
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    1120mg, iv, q3w
  • Bevacizumab — DRUG
    15mg/kg, iv, q3w
  • HAIC of FOLFOX — DRUG
    HAIC (FOLFOX): oxaliplatin 100mg/m2, 4h, day 1 + leucovorin 300mg/m2, 2h, day 1 + fluorouracil 500mg/m2, 20min, day 1 + fluorouracil 1500mg/m2, 20h, q3w

Study Details

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 .

Key Dates

Start date
Sep 25, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TREATMENT
    therapy of durvalumab in combination with bevacizumab, combined with HAIC followed by SBRT

Primary Outcome Measure

Conversion rate [ Time Frame: 3 MONTH ]

Central Contacts

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