A Phase 3 interventional study of Anlotinib hydrochloride capsules, Penpulimab injection and Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo in Hepatocellular Carcinoma, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 67 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 3, Interventional, and Treatment
The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS).
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 480 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 320 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle.
Drug: Anlotinib hydrochloride capsules, Penpulimab injection
Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.
Drug: Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo
Drug pages: Catequentinib hydrochloride · Penpulimab
Anlotinib hydrochloride capsules is a multitargeted receptor tyrosine kinase inhibitor. Penpulimab injection is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1).
placebo control, no active substance.
Recurrence-free survival (RFS)
RFS assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, or death from any cause, whichever occurred first.
Time frame: Baseline up to 3 years.
Time to recurrence(TTR)
TTR assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, whichever occurred first.
Time frame: Baseline up to 3 years.
Time to extrahepatic metastasis or macrovascular invasion
Time to extrahepatic metastasis or macrovascular invasion as assessed by the investigator.
Time frame: Baseline up to 3 years.
Overall survival (OS)
OS defined as the time from the date of randomization until the date of death due to any cause.
Time frame: Baseline up to 3 years.
Objective response rate (ORR) after first recurrence
subjects with evaluable tumor lesion status who were cross-treated with Anlotinib hydrochloride capsules combined with Penpulimab injection developed complete response or partial response after a first HCC relapse as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: Baseline up to 3 years.
Started May 2023 (actual). Primary completion is estimated for Aug 2024, 15 months after the start.
Of 47 industry-sponsored phase 3 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 63. This study's planned 15 months is below that.
Counting every sponsor, half of 130 studies reached it within 57 months; a quarter within 44 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Catequentinib hydrochloride · Penpulimab
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. →