SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma

Sponsor
Fujian Cancer Hospital
Study ID
NCT06538935
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • adbelimumab — DRUG
    adbelimumab：1200mg iv d1 q3w
  • SBRT — PROCEDURE
    SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）; tumor thrombus dose 30Gy /5-6F;
  • apatinib — DRUG
    apatinib：250mg po, qd

Study Details

This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.

Key Dates

Start date
Jan 31, 2025
Status verified
Jul 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Perioperative queue
    SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）； Adbelimumab: 2-3 cycles of neoadjuvant therapy before surgery, 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Before surgery, the patient's surgical pathology samples still need to be collected. After surgery, patients would receive Adbelimumab and Apatinib as adjuvant therapy .No more than 17 cycles before and after surgery.
  • Experimental: Conversion queue
    SBRT: tumor thrombus dose 30Gy /5-6F; Primary tumor dose is referred to Perioperative queue; Adbelimumab: 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Treatment continues till PD,death,intolerable toxicity,or meet the criteria for Successful transformation(the maximum duration of adbelizumab combined with Apatinib conversion therapy was 1 year).

Primary Outcome Measure

Pathological complete response Rate (Perioperative cohort) [ Time Frame: 4 months ]

Central Contacts

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