Condition: Hepatocellular Carcinoma (HCC) · Sponsor: Abbisko Therapeutics Co, Ltd
This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio. Patients will receive assigned study treatment, every 28-day treatment cycle within 1 day of randomization until disease progression, intolerable toxicity, start of new anti-tumor therapy, death, patient refuse to continue treatment, loss to follow-up, or other reasons leading to treatment discontinuation. Immediate BICR review is required for patients with radiographic disease progression as assessed by the investigator. If disease progression is assessed by BICR, the investigator is allowed to unblind after disease progression according to the protocol-specified procedures. After unblinding, patients in the experimental arm, study drug should be discontinued. Patients in the control arm may be transferred to receive ABSK-011 plus BSC after assessment.
This description comes directly from the study's public registry record.
Xiaoping Chen · +86-027-83665312 · chenxpchenxp@163.com
Qi Cheng · chengqi@hust.edu.cn
Always discuss trial participation with your own doctor first.
| Anhui Provincial Cancer Hospital | Hefei, Anhui, China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
| The First Affiliated Hospital of USTC | Hefei, Anhui, China | Recruiting |
| The Second Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
| Beijing Tsinghua Changgung Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Peking Union Medical College Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Chongqing university cancer hospital | Chongqing, Chongqing Municipality, China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Recruiting |
| Fujian Cancer Hospital | Fuzhou, Fujian, China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou, Guangdong, China | Recruiting |
| The Second Affiliated Hospital of Guilin Medical University | Guilin, Guangxi, China | Recruiting |
+ 39 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07327034