Clinical trial · Interventional
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
NCT05954897CI-TRIAL-00068109recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- interventionNames
- Drug: Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable,through study completion, an average of 12 months
- description
- The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR) under mRECIST criteria
Secondary outcomes (4)
- measure
- Progression-free survival
- timeFrame
- From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years or older. 2. 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. 3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system. 4. 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. 5. No prior treatment for HCC. 6. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). 7. Performance status (PS) ECOG score ≤1. 8. Child-Pugh score ≤7. 9. Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up 10. 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. Exclusion Criteria: 1. Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type; 2. Previous liver transplantation; 3. History of other malignancies; 4. Previous history of severe mental illness; 5. Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion; 6. Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy; 7. Other reasons were judged by the investigator to be unable to enroll.
References
Publications (0)
Data not yet available
No reference posted for this study.