Clinical trial · Observational
HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)
Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors as First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Target Trial Emulation Study
- 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)
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCLC Stage C Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| HCC - Hepatocellular Carcinoma | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
| Hepatic Arterial Infusion Chemotherapy | — | UNRESOLVED | — |
| Lenvatinib | — | UNRESOLVED | — |
| PD-1 Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hepatic artery infusion chemotherapy | Procedure | — | UNRESOLVED |
| Lenvatinib + PD-1 monoclonal antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HAIC plus Lenvatinib and PD-1 inhibitors
- description
- Each patient should receive at least 2 cycles of HAIC, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months.
- interventionNames
- Procedure: hepatic artery infusion chemotherapy
- Drug: Lenvatinib + PD-1 monoclonal antibody
- label
- Lenvatinib plus PD-1 inhibitors
- description
- Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib.
- interventionNames
- Drug: Lenvatinib + PD-1 monoclonal antibody
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Up to approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 80 years old; 2. Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline; 3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria; 4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa. 5. Presence of PVTT; 6. Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib. 7. Child-Pugh class A or B7; 8. Tumor burden meets up to 7 out criteria. Exclusion Criteria: 1. Patients who took anti-tumor treatments before the combination therapy; 2. With other malignant tumors; 3. incomplete data.
References
Publications (1)
- DERIVEDLiu J, Zhang S, Shao H. Hepatic arterial infusion chemotherapy plus lenvatinib and PD-1 inhibitors versus lenvatinib plus PD-1 inhibitors as first-line treatment for hepatocellular carcinoma with high tumour burden and portal vein tumour thrombus (CHANCE 2416): study protocol of a multicentre, retrospective, target trial emulation design. BMJ Open. 2025 Sep 9;15(9):e099510. doi: 10.1136/bmjopen-2025-099510. PMID 40930561