SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma
NCT ID: NCT06538935
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-01-31
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401)
NCT06261125
Apatinib in Combination With Stereotactic Body Radiation Therapy (SBRT) Treatment for Symptomatic Metastatic Prostate Cancer
NCT02998242
Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)
NCT06313190
Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Hepatocellular Carcinoma
NCT03857815
SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma
NCT04434989
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
adbelimumab
adbelimumab：1200mg iv d1 q3w
SBRT
SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）; tumor thrombus dose 30Gy /5-6F;
apatinib
apatinib：250mg po, qd
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).
adbelimumab
adbelimumab：1200mg iv d1 q3w
SBRT
SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）; tumor thrombus dose 30Gy /5-6F;
apatinib
apatinib：250mg po, qd
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
adbelimumab
adbelimumab：1200mg iv d1 q3w
SBRT
SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）; tumor thrombus dose 30Gy /5-6F;
apatinib
apatinib：250mg po, qd
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ≥18 years of age，Male or female
3. Subjects are diagnosed with histologically or cytologically confirmed HCC
4. Subjects haven't received any systemic treatment for HCC before admission.
5. Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard
6. ECOG performance status of 0 or 1
7. Life expectancy ≥ 12 weeks
8. Subjects are diagnosed with resectable stage IB- IIIA HCC cancer.
9. The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)
* Absolute neutrophil count≥1.5×109 /L
* Platelets≥75×109/L ;Hemoglobin≥9.0 g/dL; Serum albumin≥3g/dL
* Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）
* Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)
* Serum creatinine ≤1.5×ULN or creatinine clearance \> 60 mL/minute (using Cockcroft-Gault formula)
Exclusion Criteria
2. Be ready for or previously received organ or allogenic bone marrow transplantation
3. Moderate-to-severe ascites with clinical symptoms
4. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.
5. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment.
6. Known genetic or acquired hemorrhage or thrombotic tendency.
7. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
8. Cardiac clinical symptom or disease that is not well controlled.
9. Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment ；Subjects have had a hypertensive crisis or hypertensive encephalopathy
10. Patient develops severe vascular disease within 6 months before the start of study treatment.
11. Patients with severe, unhealed or split wounds and active ulcers or untreated fractures.
12. Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment.
13. Factors to affect oral administration (such as patients unable to swallow oral medications, malabsorption syndrome etc. situations evidently affect drug absorption).
14. Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.
15. There is evidence of intragastric gas that cannot be explained by puncture or recent surgery.
16. Previous or current presence of metastasis to central nervous system.
17. Subjects have history of hepatic encephalopathy.
18. The subject has an interstitial lung disease that is symptomatic or may interfere with the discovery or management of suspected drug-related lung toxicity; previous and current subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-associated pneumonia, severe impaired lung function, etc.
19. The patient has any active autoimmune disease or a history of autoimmune disease expected relapse.
20. Severe infection within 4 weeks prior to the start of study treatment.
21. A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease.
22. The patient is pregnant or breastfeeding.
23. Subjects were vaccinated with live attenuated vaccine within 28 days before the first dose or expected to receive this vaccine within 60 days after the last dose or during the study period.
24. Treatment of other investigational product(s) within 28 days prior to the start of study treatment.
25. Other factors deemed unsuitable for participation in this study by the researchers.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fujian Cancer Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.