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NCT07045558Not yet recruiting

HAIC + Atezolizumab Plus Bevacizumab in Unresectable HCC

HAIC in Combination With Atezolizumab Plus Bevacizumab as Conversion Therapy in Unresectable Hepatocellular Carcinoma: a Single-arm, Prospective Study

Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Patients with unresectable HCC will be enrolled in the cohort and will receive the combination therapy of HAIC and atezolizumab plus bevacizumab. The objective response rate is the primary endpoint, and the secondary endpoint includes disease control rate, conversion rate, pathologic complete response, major pathologic response, progression-free survival, recurrence-free survival, overall survival, quality of life, and safety.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
28 (estimated)
First submitted
10 Jun 2025
Start date
1 Aug 2025
Primary completion date
31 Jul 2026
Lead sponsor
RenJi Hospital
NCT number
NCT07045558

What you commit to

  • Study type: Observational
  • Planned participants: 28
  • From 1 Aug 2025 to the primary completion date, 31 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent autoimmune diseases, organ/hematopoietic stem cell transplantation history, or other malignancies.
  • Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), bevacizumab, molecular targeted therapy, atezolizumab, or other PD-1/PD-L1 inhibitors received before enrollment.
  • Major surgery, chemotherapy, radiotherapy, or systemic therapy for lesions received within 1 month before enrollment.
  • Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (\>10 mg/day prednisone or other equivalent drugs) within 14 days before enrollment.
  • Other contraindications for interventional therapy, molecular targeted therapy, or immunotherapy.
  • Inability to undergo scheduled follow-up or concurrent participation in other clinical trials that may interfere with this study.

Other illness

  • Impaired consciousness, inability to cooperate with treatment, or active psychiatric disorders.
  • Severe esophageal varices or high risk of bleeding assessed by endoscopy.
  • Evidence of decompensated liver function, including ascites, gastrointestinal bleeding, or hepatic encephalopathy.
  • Severe organ dysfunction in major organs such as the liver, kidneys, heart, lungs, or brain.

Other

  • Known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid HCC, or fibrolamellar carcinoma.
  • Other severe comorbidities deemed by the investigator to jeopardize patient safety or compromise study completion.

Who the study is looking for

  • Patients between 18 and 75 years old, with no gender restrictions.
  • Confirmed unresectable hepatocellular carcinoma (BCLC stage B/C) by histology, cytology, or clinical diagnosis.
  • At least one measurable lesion based on RECIST version 1.1.
  • Child-Pugh class A or B7.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
  • No prior systemic therapy received, with an expected survival ≥12 weeks.
  • Adequate organ function meeting the following criteria:
    • Hematological parameters (without blood transfusion within 14 days): Hemoglobin (Hb) ≥80 g/L, White blood cell count (WBC) ≥3 × 10⁹/L, Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, Platelet count (PLT) ≥50 × 10⁹/L; B. Biochemical parameters: Total bilirubin (TBIL) \<1.5 × upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 × ULN, Serum creatinine (Cr) ≤1.5 × ULN.
  • Contraception requirements: Women of childbearing age must have a negative serum or urine pregnancy test (HCG) within 7 days before enrollment and agree to use effective contraceptive methods during the trial period and for 8 weeks after the last dose. Men must either have undergone surgical sterilization or agree to use appropriate contraceptive methods during the trial period and for 8 weeks after the last dose.
  • Willingness to voluntarily participate in the study, with good compliance and commitment to follow-up.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.