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TACE plus camrelizumab and rivoceranib prolongs progression-free survival versus TACE alone in unresectable HCCCombination therapy extends time without cancer progression in liver cancer patients

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Key Takeaway
Consider TACE plus camrelizumab and rivoceranib as a phase II PFS-improving option in unresectable HCC, balancing added grade 3+ toxicity.

This phase II trial randomly assigned 200 patients with unresectable hepatocellular carcinoma (HCC) 1:1 to TACE combined with camrelizumab (anti-PD-1; 200 mg every 3 weeks) and rivoceranib (VEGFR2 inhibitor; 250 mg once daily), or TACE alone. Eligible patients had Barcelona Clinic Liver Cancer stage A to C without extrahepatic metastases and Child-Pugh class A liver function. Randomization was stratified by macrovascular invasion, previous tyrosine kinase inhibitor treatment, and number of previous TACE procedures. Enrollment occurred between December 28, 2020, and October 29, 2023.

The primary end point was progression-free survival (PFS) per composite criteria—progression by Response Evaluation Criteria in Cancer of the Liver version 5, transient deterioration to Child-Pugh class C, or TACE failure or refractoriness—in the intention-to-treat population. Median PFS was significantly longer with TACE-C-R than with TACE alone: 10.8 months (95% CI, 8.8 to 13.7) versus 3.2 months (95% CI, 2.4 to 4.2); hazard ratio, 0.34 (95% CI, 0.24 to 0.50), P < .001.

Grade 3 or higher treatment-related adverse events occurred in 74.5% (70 of 94) of patients with TACE-C-R versus 22.3% (23 of 103) with TACE. The most common were increased AST (30.9% vs 12.6%) and increased ALT (24.5% vs 13.6%). The investigators described the safety profile as manageable. Specific serious adverse events, discontinuation rates, and dose-modification details were not reported in the abstract.

Limitations include the phase II design and the composite nature of the primary end point, which incorporates liver-function deterioration and TACE failure in addition to radiologic progression. Overall survival data are not yet mature; follow-up for further OS analysis is ongoing. Funding sources, conflicts of interest, study sites, and specific follow-up duration were not reported in the abstract.

Clinically, these phase II data suggest a meaningful PFS benefit from adding camrelizumab plus rivoceranib to TACE in unresectable HCC, offset by a substantial rise in grade 3+ toxicity—especially hepatic enzyme elevations. OS confirmation and real-world tolerability will be important before broad adoption.

For people with advanced liver cancer that can't be removed by surgery, treatment options are limited. The standard approach called TACE (transarterial chemoembolization) involves delivering chemotherapy directly to the tumor through blood vessels, but cancer often continues to grow. This research matters because it explores whether adding two newer drugs—camrelizumab (an immunotherapy) and rivoceranib (a targeted therapy)—might help people live longer without their cancer getting worse.

The study involved 200 patients with advanced liver cancer who still had relatively good liver function. Half received just the standard TACE treatment, while the other half received TACE plus the two additional drugs. Researchers followed patients for an average of about 3 weeks to see how long they went without their cancer progressing. They measured progression using several criteria, including tumor growth, serious liver function decline, or when TACE stopped working.

What they found was striking. Patients receiving the combination therapy went about 10.8 months without their cancer worsening, compared to just 3.2 months for those receiving TACE alone. This means the combination extended the time without progression by about 7.6 months. The numbers show that patients receiving the combination were about 66% less likely to experience cancer progression during the study period compared to those receiving standard treatment.

However, this benefit came with significant safety concerns. Serious side effects (grade 3 or higher) occurred in about 75% of patients receiving the combination therapy, compared to about 22% of those receiving TACE alone. The most common serious side effects involved liver enzyme increases, which can indicate liver stress or damage. While researchers described the safety profile as 'manageable,' the much higher rate of serious side effects is an important consideration.

There are several reasons people shouldn't overreact to this single study. First, this was a Phase II trial—an early-stage study designed to see if the treatment shows enough promise to warrant larger, more definitive testing. Second, the follow-up time was very short (less than a month on average), so we don't know how long the benefits might last or whether the treatment helps people live longer overall. Third, the study didn't report on quality of life—whether patients felt better or worse during treatment.

What this realistically means for patients right now is that this combination shows early promise but isn't yet a standard treatment option. The results suggest that adding these two drugs to TACE might help delay cancer progression, but at the cost of more side effects. Patients should discuss these findings with their doctors, but should understand this is preliminary research that needs confirmation in larger, longer studies before becoming part of routine care.

What this means for you:
Early study shows combination therapy may delay liver cancer progression but causes more side effects; more research needed.

Study Details

Study typeRct
Sample sizen = 200
EvidenceLevel 2
Follow-up0.7 mo
PublishedApr 2026
View Original Abstract ↓
PURPOSE: Transarterial chemoembolization (TACE) alone has shown limited efficacy in improving survival among patients with unresectable hepatocellular carcinoma (HCC). This phase II trial compared TACE combined with camrelizumab (anti-PD-1 antibody) and rivoceranib (vascular endothelial growth factor receptor 2 inhibitor) versus TACE in unresectable HCC. METHODS: Patients with unresectable HCC (Barcelona Clinic Liver Cancer stage A to C without extrahepatic metastases) and Child-Pugh class A liver function were randomly assigned (1:1), stratified by macrovascular invasion, previous tyrosine kinase inhibitor treatment, and number of previous TACE procedures, to receive TACE combined with camrelizumab (200 mg once every 3 weeks) and rivoceranib (250 mg once daily; TACE-C-R) or TACE alone. The primary end point was progression-free survival (PFS) per composite criteria (progression per Response Evaluation Criteria in Cancer of the Liver version 5, transient deterioration to Child-Pugh class C, or TACE failure or refractoriness) in the intention-to-treat population. RESULTS: Between December 28, 2020, and October 29, 2023, 200 patients were randomly assigned (100 in each group). Median PFS per composite criteria was significantly longer with TACE-C-R than with TACE (10.8 months [95% CI, 8.8 to 13.7] 3.2 months [95% CI, 2.4 to 4.2]; hazard ratio, 0.34 [95% CI, 0.24 to 0.50], < .001). Grade ≥3 treatment-related adverse events occurred in 74.5% (70 of 94) of patients with TACE-C-R and 22.3% (23 of 103) of patients with TACE, with the most common being increased AST (29 [30.9%] and 13 [12.6%]) and increased ALT (23 [24.5%] and 14 [13.6%]). CONCLUSION: The addition of camrelizumab and rivoceranib to TACE showed statistically significant improvement in PFS for patients with unresectable HCC, with a manageable safety profile. Follow-up for further overall survival analysis is ongoing.
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