Clinical trial · Interventional
Camrelizumab Combined With Rivoceranib and Hepatic Arterial Infusion Chemotherapy (HAIC) as Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma(HCC)
Camrelizumab and Rivoceranib Plus HAIC as Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2/3 Study
NCT06796803CI-TRIAL-00118367recruitingPhase 2 / Phase 3ClinicalTrials.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)
The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.
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 |
|---|---|---|---|
| Potentially Resectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| camerlizumab + rivoceranib | Drug | — | UNRESOLVED |
| camrelizumab combined with rivoceranib and HAIC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- camrelizumab + rivoceranib + HAIC
- interventionNames
- Drug: camrelizumab combined with rivoceranib and HAIC
- type
- ACTIVE_COMPARATOR
- label
- camrelizumab + rivoceranib
- interventionNames
- Drug: camerlizumab + rivoceranib
Primary outcomes (2)
- measure
- R0 rate
- timeFrame
- 24 months
- description
- R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed Informed Consent Form (ICF) 2. Aged ≥18 years and ≤75 years at time of signing ICF 3. Documented diagnosis of HCC confirmed by histology/cytology or clinically 4. Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium 5. Patients with recurrence following prior radical surgical resection must have undergone the initial surgery at least 5 years prior to study entry 6. At least one measurable lesion (per RECIST v1.1) untreated lesion 7. ECOG performance status of 0 or 1 8. Child-Pugh ≤7 score 9. Life expectancy ≥12 weeks 10. Adequate organ function 11. No prior anti-tumor systemic therapies for HCC Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC 2. Other active malignant tumor except HCC within 5 years or simultaneously 3. Prior locoregional therapy (such as TACE、TAE、HAIC、TARE) 4. There is an absolute contraindication to HAIC 5. History of hepatic encephalopathy 6. Diffuse HCC, intrahepatic tumor burden \> 50% 7. PVTT reaching the superior mesenteric vein, and bilateral PVTT are present 8. Clinically significant ascites 9. Prior allogeneic stem cell or solid organ transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.