An interventional study of toripalimab and Lenvatinib in Recurrent Hepatocellular Cancer, sponsored by Henan Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Henan Cancer Hospital · Not applicable, Interventional, and Treatment
This study is a multi-center, prospective, single-arm, open-design phase II clinical study, mainly to explore the clinical effectiveness and safety of radiofrequency ablation combined with anti-PD-1 antibody toripalimab and lenvatinib in patients with short-term recurrence of hepatocellular carcinoma.
Primary endpoint: Recurrence-free survival time (RFS). Secondary endpoints: safety (incidence of adverse events); time to recurrence (TTR); time to local recurrence (TTLR); 12-month recurrence-free survival rate; overall survival (OS); 12 months and 24 Month overall survival rate.
Treatment plan: Patients undergo radiofrequency ablation, 3-5 days after radiofrequency ablation, lenvatinib 12 mg (body weight ≥ 60 kg) or 8 mg (body weight \<60 kg) orally, once a day; toripalimab is a fixed dose of 240 mg, once every 3 weeks, intravenous infusion on the first day of each cycle, the infusion time is no less than 60 minutes.Combination therapy until tumor recurrence, disease progression, death or intolerable toxicity occurs.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 90 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: toripalimab · Drug: Lenvatinib · Device: Radiofrequency ablation
240mg,ivgtt, every three weeks as a cycle, the first day of each cycle.
12mg (weight ≥60kg) or 8mg (weight \<60kg) orally, once a day
ultrasound-guided percutaneous radiofrequency ablation of recurrent hepatocellular carcinoma
RFS
Recurrence-free survival time
Time frame: up to 36 months
safety
Adverse event rate
Time frame: 24 months
TTR
time to recurrence
Time frame: up to 36 months
1-year RFS%
1-year recurrence-free survival rate
Time frame: 12 months
OS
overall survival
Time frame: 2025
1-year OS%
1-year overall survival rate
Time frame: 12 months
2-year OS%
2-year overall survival rate
Time frame: 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Henan Cancer Hospital