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NCT05954897RecruitingPhase 2

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study

Source: ClinicalTrials.gov · Last updated 20 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
29 (estimated)
First submitted
12 Jul 2023
Start date
1 Sept 2023
Primary completion date
1 Jan 2026
Lead sponsor
Guangdong Provincial People's Hospital
NCT number
NCT05954897

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 29
  • From 1 Sept 2023 to the primary completion date, 1 Jan 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

  • Previous liver transplantation;
  • Previous history of severe mental illness;
  • Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;

Other illness

  • History of other malignancies;
  • Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;

Other

  • Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
  • Other reasons were judged by the investigator to be unable to enroll.

Who the study is looking for

  • 18 years or older.
  • HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria.
  • Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
  • A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm.
  • No prior treatment for HCC.
  • At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST).
  • Performance status (PS) ECOG score ≤1.
  • Child-Pugh score ≤7.
  • Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up
  • Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 \^ 9/L; PLT ≥ 75 x 10 \^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal.

Age in the registry: 18 years to - · 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
Guangdong Provincial People's Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

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