NCT07285850Toboroz2/3. fázis
The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD
The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 16.
Rövid összefoglaló (regiszter, angolul)
This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2025. aug. 17.
- Kezdés
- 2025. okt. 20.
- Elsődleges befejezés
- 2026. aug. 30.
- Fő szponzor
- Eastern Hepatobiliary Surgery Hospital
- Betegségek
- Máj- és epeúti rák, Zsírmáj (MASLD/MASH)
- NCT-szám
- NCT07285850
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Tervezett résztvevők: 20
- 2025. okt. 20. és az elsődleges befejezés (2026. aug. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy
- Participation in another clinical drug or therapy trial within 4 weeks before first study dose
- Major surgery within 4 weeks prior to first study dose, or incomplete recovery from surgery
- Radiotherapy within 2 weeks before first study dose
- Current use of immunosuppressants or corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks
- Events within 6 months before first dose (e.g., DVT, PE, MI, PCI, ACS, CABG, stroke, TIA, embolism)
- Use of warfarin or coumarin derivatives within 14 days before or during treatment
Más betegség
- History or presence of primary immunodeficiency or active autoimmune disease
- History of organ transplantation or hematopoietic stem cell transplantation
- Positive for HIV antibody or Treponema pallidum antibody, or active hepatitis B/C infection
- Allergy to recombinant humanized PD-1 monoclonal antibody, VEGF monoclonal antibody, or components
- Severe cardiovascular disease within 12 months (e.g., CAD, CHF ≥ II, arrhythmias, MI)
- History of GI surgery, obstruction, bleeding, dysfunction, or malabsorption affecting drug absorption
- Severe uncontrolled infection or comorbidity, or moderate/severe renal impairment
- Active pulmonary disease (interstitial pneumonia, COPD, asthma, tuberculosis history)
- Significant bleeding within 3 months (e.g., hemoptysis ≥ 2.5 mL, GI bleeding, varices, ulcers, vasculitis)
- Known hereditary/acquired bleeding or thrombotic disorders (e.g., hemophilia, thrombocytopenia)
- History of substance abuse or mental disorders affecting compliance
- Other severe acute/chronic conditions increasing risk or confounding results
- Poor compliance or other conditions deemed unsuitable for trial participation
Laborértékek
- Abnormal coagulation (INR > 2.0, PT > 16 s), bleeding tendency, or thrombolytic/anticoagulant therapy (except prophylaxis)
Egyéb
- Excessive alcohol consumption (weekly ethanol intake: males < 210 g, females < 140 g)
- Pregnant or breastfeeding women, or positive pregnancy test at baseline
- Central nervous system metastases diagnosed by CT, MRI, or PET-CT
- Symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical intervention
A regiszterben nem jelölt feltételek
- Eligibility Criteria Inclusion Criteria
- Age ≥ 18 years old (gender not limited)
- ECOG performance status of 0-1
- Preoperative imaging diagnosis of advanced hepatocellular carcinoma (BCLC stage C or D, unsuitable for surgery)
- Ultrasound or MRI indicating moderate to severe fatty liver (Fibroscan CAP > 268 dB/m or MR fat score > 10%)
- Willing to use contraceptive measures during the trial period
- Expected survival time ≥ 3 months
- At least one measurable lesion (per RECIST 1.1) that has not been irradiated
- Organ function levels (within 7 days before first study medication) must meet the following:
- Hematopoietic function: ANC ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L, no transfusion within 14 days
- Liver function: TBIL ≤ 1.5×ULN, AST/ALT/ALP ≤ 2.5×ULN, serum creatinine ≤ 1.5×ULN, CrCl ≥ 50 mL/min, ALB ≥ 30 g/L, Child-Pugh A
- Coagulation function: INR and APTT ≤ 1.5×ULN or within therapeutic range if on anticoagulants
- Renal function: urinary protein ≤ 1+ (or ≤1 g/24h if >1+)
- Cardiac function: ECG normal or clinically insignificant, LVEF > 50%
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dosing
- Men and women of reproductive potential must use effective contraception during and for 12 months after treatment
- Participants must voluntarily provide informed consent and have good compliance
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital | Shanghai | Kína | Toboroz |
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